Valaitis SR, Rogers RG
Int Urogynecol J Pelvic Floor Dysfunct. 2006 Aug 1;.e-pub
Many challenges face practicing surgeons in today's medical environment. Decreasing revenues create a need for increasing patient volume. Increasing costs of malpractice insurance not only provide financial burdens, but also cause many practitioners to relocate or change the focus of their practice. Technological advancements with the rapid emergence of new procedures and medical devices tax the practicing physician's ability to keep apace of changes. These changes, in combination with increased focus on patient safety and physician competence, place even greater demands on practicing in the surgical subspecialties. In this environment, finding time to improve skills and gain competence in new procedures is a daunting task. This article addresses the topic of surgical competence, provides insight into how to learn to do and prove competence to perform new surgical procedures, as well as reviews the opportunities available for self-evaluation currently available for the practicing surgeon.
Pelvic floor digest.
Tech Coloproctol. 2006 Jun;10(2):154-7.
This section's aim is to stimulate readers of Techniques in Coloproctology to increase their interest in problems of the front and middle pelvic floor regions. Articles can be submitted to the Journal on any of these topics.The section publishes a small sample of the Pelvic Floor Digest. The PFD reproduces online (www.pelvicfloordigest.org) titles and abstracts selected from about 200 journals, divided into 10 sections. Its goal is to develop in the single individual an interdisciplinary culture in this field.
Paranoia over privacy.
Ann Intern Med. 2006 Aug 1;145(3):228-9; discussion 229-30.
Understanding the Peer Review Process.
World J Surg. 2006 Jul 21;. e-pub
The Journal of the Future Is Here Today.
World J Surg. 2006 Jul 21;.e-pub
Scientific publishing has undergone a complete transformation in the last two decades. While the process of peer review may differ little from what it was during the last 50 years, electronic indexing, electronic access, and now electronic submission of scientific manuscripts has transformed the surgical journal in the last decade. In fact, the editorial office of the journal has contracted to a workstation, a fax machine, a telephone, and a storage locker for the aging paper records.
Postnatal myocardial augmentation with skeletal myoblast-based fetal tissue engineering.
Fuchs JR, Nasseri BA, Vacanti JP, Fauza DO
Surgery. 2006 Jul;140(1):100-7.
BACKGROUND: Cardiac anomalies constitute the most common birth defects, many of which involve variable myocardial deficiencies. Therapeutic options for structural myocardial repair remain limited in the neonatal population. This study was aimed at determining whether engineered fetal muscle constructs undergo milieu-dependent transdifferentiation after cardiac implantation, thus becoming a potential means to increase/support myocardial mass after birth. METHODS: Myoblasts were isolated from skeletal muscle specimens harvested from fetal lambs, labeled by transduction with a retrovirus-expressing green fluorescent protein, expanded in vitro, and then seeded onto collagen hydrogels. After birth, animals underwent autologous implantation of the engineered constructs (n = 8) onto the myocardium as an onlay patch. Between 4 and 30 weeks postoperatively, implants were harvested for multiple analyses. RESULTS: Fetal and postnatal survival rates were 89% and 100%, respectively. Labeled cells were identified within the implants at all time points by immunohistochemical staining for green fluorescent protein. At 24 and 30 weeks postimplantation, donor cells double-stained for green fluorescent protein and Troponin I, while losing skeletal (type II) myosin expression. CONCLUSIONS: Fetal skeletal myoblasts engraft in native myocardium up to 30 weeks after postnatal, autologous implantation as components of engineered onlay patches. These cells also display evidence of time-dependent transdifferentiation toward a cardiomyocyte-like lineage. Further analysis of fetal skeletal myoblast-based constructs for the repair of congenital myocardial defects is warranted.
Lost and found: cardiac stem cell therapy revisited.
J Clin Invest. 2006 Jul;116(7):1838-40.
Several clinical trials of bone marrow stem cell therapy for myocardial infarction are ongoing, but the mechanistic basis for any potential therapeutic effect is currently unclear. A growing body of evidence suggests that the potential improvement in cardiac function is largely independent of cardiac muscle regeneration. A study by Fazel et al. in this issue of the JCI provides evidence that bone marrow-derived c-kit+ cells can lead to an improvement in cardiac function in mutant hypomorphic c-kit mice that is independent of transdifferentiation into either cardiac muscle or endothelial cells, but rather is associated with the release of angiogenic cytokines and associated neovascularization in the infarct border zone (see the related article beginning on page 1865). These findings suggest the potential therapeutic effect of specific paracrine pathways for angiogenesis in improving cardiac function in the injured heart.
Tissue Engineering of Heart Valves In Vivo Using Bone Marrow-derived Cells.
Kim SS, Lim SH, Hong YS, Cho SW, Ryu JH, Chang BC, Choi CY, Kim BS
Artif Organs. 2006 Jul;30(7):554-7.
In this study, we tissue-engineered heart valves in vivo using autologous bone marrow-derived cells (BMCs). Canine BMCs were differentiated into endothelial cell (EC)-like cells and myofibroblast (MF)-like cells. Decellularized porcine pulmonary valves were seeded with BMCs and implanted to abdominal aorta and pulmonary valve of bone marrow donor dogs. Histological examination of the explants identified the regeneration of valvular structures expressing CD31 and smooth muscle alpha-actin, indicating the presence of EC-like and MF-like cells in the grafts at 3 and 1 week, respectively, after implantation. Fluorescent microscopic examinations identified the presence of fluorescently labeled cells in the explants, indicating that the implanted BMCs survived and participated in the heart valve reconstitution. This study reports, for the first time, on tissue engineering of heart valve in vivo using BMCs.
Biomaterials and strategies for nerve regeneration.
Huang YC, Huang YY
Artif Organs. 2006 Jul;30(7):514-22.
Nerve regeneration is a complex biological phenomenon. Once the nervous system is impaired, its recovery is difficult and malfunctions in other parts of the body may occur because mature neurons do not undergo cell division. To increase the prospects of axonal regeneration and functional recovery, researches have focused on designing "nerve guidance channels" or "nerve conduits." When developing ideal tissue-engineered nerve conduits, several components come to mind. They include a biodegradable and porous channel wall, the ability to deliver bioactive growth factors, incorporation of support cells, an internal oriented matrix to support cell migration, intraluminal channels to mimic the structure of nerve fascicles, and electrical activities. This article reviews the factors that are critical for nerve repair, and the advanced technologies that are explored to fabricate nerve conduits. To more accurately mimic natural repair in the body, recent studies have focused on the use of various advanced approaches to create ideal nerve conduits that combine multiple stimuli in an effort to better mimic the complex signals normally found in the body.
Sham nepotism as a result of intrinsic differences in brood viability in ants.
Holzer B, Kummerli R, Keller L, Chapuisat M
Proc Biol Sci. 2006 Aug 22;273(1597):2049-52.
Not only in the human universities, etc, but also "in animal societies, cooperation for the common wealth and latent conflicts due to the selfish interests of individuals are in delicate balance. In many ant species, colonies contain multiple breeders and workers interact with nestmates of varying degrees of relatedness. Therefore, workers could increase their inclusive fitness by preferentially caring for their closest relatives, yet evidence for nepotism in insect societies remains scarce and controversial. We experimentally demonstrate that workers of the ant Formica exsecta do not discriminate between highly related and unrelated brood, but that brood viability differs between queens. We further show that differences in brood viability are sufficient to explain a relatedness pattern that has previously been interpreted as evidence for nepotism. Hence, our findings support the view that nepotism remains elusive in social insects and emphasize the need for further controlled experiments".
Mast cells facilitate local VEGF release as an early event in the pathogenesis of postoperative peritoneal adhesions.
Cahill RA, Wang JH, Soohkai S, Redmond HP
Surgery. 2006 Jul;140(1):108-12.
BACKGROUND: Peritoneal injury sustained at laparotomy may evoke local inflammatory responses that result in adhesion formation. Peritoneal mast cells are likely to initiate this process, whereas vascular permeability/endothelial growth factor (VEGF) may facilitate the degree to which subsequent adhesion formation occurs. METHODS: Mast cell deficient mice (WBB6F1-/-), along with their mast cell sufficient counterparts (WBB6F1+/+), underwent a standardized adhesion-inducing operation (AIS) with subsequent sacrifice and adhesion assessment 14 days later in a blinded fashion. Additional CD-1 and WBB6F1+/+, and WBB6F1-/- mice were killed 2, 6, 12, and 24 hours after operation for measurement of VEGF by ELISA in systemic serum and peritoneal lavage fluid. Two further groups of CD-1 mice underwent AIS and received either a single perioperative dose of anti-VEGF monoclonal antibody (10 mug/mouse) or a similar volume of IgG isotypic antibody and adhesion formation 2 weeks later was evaluated. RESULTS: WBB6F1-/- mice had less adhesions then did their WBB6F1+/+ counterparts (median [interquartile range] adhesion score 3[3-3] vs 1.5[1-2] respectively; P < .003). Local VEGF release peaked 6 hours after AIS in both WBB6F1+/+ and CD-1 mice whereas levels remained at baseline in WBB6F1-/- mice. CD-1 mice treated with a single dose of anti-VEGF therapy during operation had less adhesions than controls (2[1.25-2] vs 3[2.25-3], P = .0002). CONCLUSIONS: Mast cells and VEGF are central to the formation of postoperative intra-abdominal adhesions with mast cells being responsible, either directly or indirectly, for VEGF release into the peritoneal cavity after operation. In tandem with the recent clinical success of anti-VEGF monoclonal antibodies in oncologic practice, our observations suggest an intriguing avenue for research and development of anti-adhesion strategy.
Analysis of surgical errors in closed malpractice claims at 4 liability insurers.
Rogers SO Jr, Gawande AA, Kwaan M, Puopolo AL, Yoon C, Brennan TA, Studdert DM
Surgery. 2006 Jul;140(1):25-33.
BACKGROUND: The relative importance of the different factors that cause surgical error is unknown. Malpractice claim file analysis may help to identify leading causes of surgical error and identify opportunities for prevention. METHODS: We retrospectively reviewed 444 closed malpractice claims, from 4 malpractice liability insurers, in which patients alleged a surgical error. Surgeon-reviewers examined the litigation file and medical record to determine whether an injury attributable to surgical error had occurred and, if so, what factors contributed. Detailed descriptive information concerning etiology and outcome was recorded. RESULTS: Reviewers identified surgical errors that resulted in patient injury in 258 of the 444 (58%) claims. Sixty-five percent of these cases involved significant or major injury; 23% involved death. In most cases (75%), errors occurred in intraoperative care; 25% in preoperative care; 35% in postoperative care. Thirty-one percent of the cases had errors occurring during multiple phases of care; in 62%, more than 1 clinician played a contributory role. Systems factors contributed to error in 82% of cases. The leading system factors were inexperience/lack of technical competence (41%) and communication breakdown (24%). Cases with technical errors (54%) were more likely than those without technical errors to involve errors in multiple phases of care (36% vs 24%, P = .03), multiple personnel (83% vs 63%, P < .001), lack of technical competence/knowledge (51% vs 29%, P < .001) and patient-related factors (54% vs 33%, P = .001). CONCLUSIONS: Systems factors play a critical role in most surgical errors, including technical errors. Closed claims analysis can help to identify priority areas for intervening to reduce errors.
Malpractice crisis: Causes of escalating insurance premiums, and implications for you.
J Fam Pract. 2006 Aug;55(8):703-6.
What has led to the current malpractice crisis? There are 2 main theories. Physicians, insurers, and hospitals generally blame lawyers and the litigation system for increasing the number of claims filed (claim frequency) and the average payout on claims (claims severity). Attorneys and consumer groups argue that malpractice insurance goes through natural cycles in costs and charges. For the rise in premiums in the current crisis, they particularly blame decreased investment returns and poor pricing decisions by insurers.
Robotic surgical education: a systematic approach to training urology residents to perform robotic-assisted laparoscopic radical prostatectomy.
Rashid HH, Leung YY, Rashid MJ, Oleyourryk G, Valvo JR, Eichel L
Urology. 2006 Jul;68(1):75-9.
OBJECTIVES: Robotic-assisted surgery using the da Vinci Surgical System is gaining popularity among urologists. However, training residents to use this system presents new challenges for surgical educators. We describe a method for training residents to perform robotic-assisted radical prostatectomy. METHODS: Residents first received da Vinci certification training followed by table-side assistance with a second attending urologist present to provide real-time instruction. After demonstrating proficiency with assistance, residents performed segments of robotic prostatectomies as the console surgeon. The procedure was divided into five steps: (a) bladder take-down, (b) endopelvic fascia and dorsal venous complex, (c) bladder neck and posterior dissection, (d) neurovascular bundles, and (e) urethral anastomosis. Performance was rated using an analog scale (0, very poor to 5, outstanding). The resident was allowed to proceed to the next step once proficiency (score greater than 3 of 5) had been demonstrated on three separate occasions. In addition, each procedure was digitally recorded and reviewed with the attending physician after the operation. RESULTS: Two chief residents underwent this training regimen. All 83 cases with surgical console involvement during a 7-month period were reviewed. The combined residents' mean operative time in minutes and overall performance (score 0 of 5 to 5 of 5) for each step were recorded. Using logistic regression analysis, a statistically significant trend was seen, with faster operative times and greater analog scores over time for both residents (P <0.005). CONCLUSIONS: A systematic approach can be used to safely and effectively train urology residents to perform robotic radical prostatectomy using the da Vinci robotic system.
Robotics in urologic surgery: An evolving new technology.
Atug F, Castle EP, Woods M, Davis R, Thomas R
Int J Urol. 2006 Jul;13(7):857-63.
Rapid technological developments in the past two decades have produced new inventions such as robots and incorporated them into our daily lives. Today, robots perform vital functions in homes, outer space, hospitals and on military instillations. The development of robotic surgery has given hospitals and health care providers a valuable tool that is making a profound impact on highly technical surgical procedures. The field of urology is one area of medicine that has adopted and incorporated robotic surgery into its armamentarium. Innovative robotic urologic surgical applications and techniques are being developed and reported everyday. Increased utilization and development will ultimately fuel the discovery of newer applications of robotic systems in urologic surgery. Herein we provide an overview of the history, development, and applications of robotics in surgery with a focus on urologic surgery.
[Should we continue to publish clinical research in French?]
Gastroenterol Clin Biol. 2006 May;30(5):657-8.
Pitfalls in systematic reviews.
Farquhar C, Vail A
Curr Opin Obstet Gynecol. 2006 Aug;18(4):433-9.
PURPOSE OF REVIEW: The term 'evidence-based medicine' means integrating individual clinical expertise with the best available external clinical evidence from systematic research. An important source for those who wish to practise evidence-based medicine is the systematic review. Systematic reviews, however, are not without their pitfalls. This review will consider the problems and challenges for researchers and users of systematic reviews. RECENT FINDINGS: Failure to adequately assess study quality, funding bias, publication bias, reliance on outcomes that provide no help in clinical decision-making, analysis errors and the incorrect use of evidence statements are all common pitfalls in systematic reviews. SUMMARY: There are several steps in completing a systematic review. These include developing the clinical question, searching for all available literature, study selection, assessment of study quality, data extraction, data analysis, interpreting the results, implications for practice and further research, and finally updating the review in a timely manner. Authors of systematic reviews need to be aware of these problems and attempt to address them so that research evidence may be of clinical value to both providers and consumers of healthcare.
Consensus statement on surgery journal authorship 2006.
J Pediatr Surg. 2006 Jun;41(6):1041-1042.
Consensus statement on surgery journal authorship--2006.
Ann Surg. 2006 Jun;243(6):713-4.
Sackings at the Canadian Medical Association Journal and editorial independence.
Van Der Weyden MB
Med J Aust. 2006 Jun 5;184(11):543-5.
A clash of purpose between a journal's editors and its owner.
Killing the messenger: should scientific journals be responsible for policing scientific fraud?
Marusic A, Marusic M
Med J Aust. 2006 Jun 19;184(12):596-7.
Media reporting on research presented at scientific meetings: more caution needed.
Woloshin S, Schwartz LM
Med J Aust. 2006 Jun 5;184(11):576-80.
OBJECTIVE: To examine media stories on research presented at scientific meetings to see if they reported basic study facts and cautions, and whether they were clear about the preliminary stage of the research. DESIGN AND SETTING: Three physicians with clinical epidemiology training analysed front-page newspaper stories (n = 32), other newspaper stories (n = 142), and television/radio stories (n = 13) identified in LexisNexis and ProQuest searches for research reports from five scientific meetings in 2002-2003 (American Heart Association, 14th Annual International AIDS Conference, American Society of Clinical Oncology, Society for Neuroscience, and the Radiological Society of North America). MAIN OUTCOME MEASURES: Media reporting of basic study facts (size, design, quantification of results); cautions about study designs with intrinsic limitations (animal/laboratory studies, studies with < 30 people, uncontrolled studies, controlled but not randomised studies) or downsides (adverse effects in intervention studies); warnings about the preliminary stage of the research presented at scientific meetings. RESULTS: 34% of the 187 stories did not mention study size, 18% did not mention study design (another 35% were so ambiguous that expert readers had to guess the design), and 40% did not quantify the main result. Only 6% of news stories about animal studies mentioned their limited relevance to human health; 21% of stories about small studies noted problems with the precision of the finding; 10% of stories about uncontrolled studies noted it was not possible to know if the outcome really related to the exposure; and 19% of stories about controlled but not randomised studies raised the possibility of confounding. Only 29% of the 142 news stories on intervention studies noted the possibility of any potential downside. Twelve stories mentioned a corresponding "in press" medical journal article; two of the remaining 175 noted that findings were unpublished, might not have undergone peer review, or might change. CONCLUSIONS: News stories about scientific meeting research presentations often omit basic study facts and cautions. Consequently, the public may be misled about the validity and relevance of the science presented.
Public reporting of hospital outcomes based on administrative data: risks and opportunities.
Scott IA, Ward M
Med J Aust. 2006 Jun 5;184(11):571-5.
In the wake of findings from the Bundaberg Hospital and Forster inquiries in Queensland, periodic public release of hospital performance reports has been recommended. A process for developing and releasing such reports is being established by Queensland Health, overseen by an independent expert panel. This recommendation presupposes that public reports based on routinely collected administrative data are accurate; that the public can access, correctly interpret and act upon report contents; that reports motivate hospital clinicians and managers to improve quality of care; and that there are no unintended adverse effects of public reporting. Available research suggests that primary data sources are often inaccurate and incomplete, that reports have low predictive value in detecting "outlier" hospitals, and that users experience difficulty in accessing and interpreting reports and tend to distrust their findings.
Predictors of publication: characteristics of submitted manuscripts associated with acceptance at major biomedical journals.
Lee KP, Boyd EA, Holroyd-Leduc JM, Bacchetti P, Bero LA
Med J Aust. 2006 Jun 19;184(12):621-6.
OBJECTIVE: To identify characteristics of submitted manuscripts that are associated with acceptance for publication by major biomedical journals. DESIGN, SETTING AND PARTICIPANTS: A prospective cohort study of manuscripts reporting original research submitted to three major biomedical journals (BMJ and the Lancet [UK] and Annals of Internal Medicine [USA]) between January and April 2003 and between November 2003 and February 2004. Case reports on single patients were excluded. MAIN OUTCOME MEASURES: Publication outcome, methodological quality, predictors of publication. RESULTS: Of 1107 manuscripts enrolled in the study, 68 (6%) were accepted, 777 (70%) were rejected outright, and 262 (24%) were rejected after peer review. Higher methodological quality scores were associated with an increased chance of acceptance (odds ratio [OR], 1.39 per 0.1 point increase in quality score; 95% CI, 1.16-1.67; P < 0.001), after controlling for study design and journal. In a multivariate logistic regression model, manuscripts were more likely to be published if they reported a randomised controlled trial (RCT) (OR, 2.40; 95% CI, 1.21-4.80); used descriptive or qualitative analytical methods (OR, 2.85; 95% CI, 1.51-5.37); disclosed any funding source (OR, 1.90; 95% CI, 1.01-3.60); or had a corresponding author living in the same country as that of the publishing journal (OR, 1.99; 95% CI, 1.14-3.46). There was a non-significant trend towards manuscripts with larger sample size (>/= 73) being published (OR, 2.01; 95% CI, 0.94-4.32). After adjustment for other study characteristics, having statistically significant results did not improve the chance of a study being published (OR, 0.83; 95% CI, 0.34-1.96). CONCLUSIONS: Submitted manuscripts are more likely to be published if they have high methodological quality, RCT study design, descriptive or qualitative analytical methods and disclosure of any funding source, and if the corresponding author lives in the same country as that of the publishing journal. Larger sample size may also increase the chance of acceptance for publication.
Medical journals and the mass media: moving from love and hate to love.
J R Soc Med. 2006 Jul;99(7):347-52.
Miss, Mister, Doctor: Puzzling titles.
Khalil A, O'brien P
J R Soc Med. 2006 Jul;99(7):335.
Miss, Mister, Doctor: An insult.
J R Soc Med. 2006 Jul;99(7):335.
Miss, Mister, Doctor: To protect and serve the patient.
Naini FB, Gill DS
J R Soc Med. 2006 Jul;99(7):334.
Miss, mister, doctor: doctor or mister?
J R Soc Med. 2006 Jul;99(7):334.
Miss, Mister, Doctor: Do surgeons wish to become doctors?
J R Soc Med. 2006 Jul;99(7):334.
Miss, Mister, Doctor: How we are titled is of little consequence.
J R Soc Med. 2006 Jul;99(7):333.
Consensus statement on surgery journal authorship-2006.
Surgery. 2006 Jun;139(6):A11-2.
Re-inventing medical work and training: a view from generation X.
Med J Aust. 2006 Jul 3;185(1):35-6.
Medical career preferences are changing, with doctors working fewer hours and seeking "work-life balance". There is an urgent need for creative workplace redesign if Australia is to have a sustainable health care system. Postgraduate medical education must adapt to changing medical roles. Curricula should be outcomes-based, should allow flexible delivery, and should consider future workforce needs.
Principles for supporting task substitution in Australian general practice.
Kidd MR, Watts IT, Mitchell CD, Hudson LG, Wenck BC, Cole NJ
Med J Aust. 2006 Jul 3;185(1):20-2.
The workforce crisis in Australian general practice provides an impetus to consider new roles for other health professionals. Any innovations need to be appraised in advance for their potential risks and benefits. We propose six principles for this appraisal. These are the need for the new roles to: support the relationship between patients and their general practitioners; be clearly defined, aligned with competency and with relevant professional registration; be supported by practice systems providing safeguards against medical error; be underpinned by a system ensuring informed patient consent to activities being undertaken by members of the general practice team; be supported by effective medical indemnity insurance and be supported with appropriate financing.
The medical care practitioner: developing a physician assistant equivalent for the United Kingdom.
Parle JV, Ross NM, Doe WF
Med J Aust. 2006 Jul 3;185(1):13-7.
A range of demographic, social and other factors are creating a crisis in the provision of clinical care in the United Kingdom for which the physician assistant (PA) model developed in the United States appears to offer a partial solution. Local and national moves are underway to develop a similar cadre of registered health care professionals in England, with the current title of medical care practitioners (MCPs). A competence and curriculum framework document produced by a national steering group has formed the basis for a recent consultation process. A limited evaluation of US-trained PAs working in the West Midlands region of England in both primary care and acute secondary care suggests that PA activity is similar to that of doctors working in primary care and to primary care doctors working in the accident and emergency setting. The planned introduction of MCPs in England appears to offer, first, an effective strategy for increasing medical capacity, without jeopardising quality in frontline clinical services; and, second, the prospect of increased flexibility and stability in the medical workforce. The deployment of MCPs may offer advantages over increasing the number of doctors or taking nurses out of nursing roles. The introduction of MCPs may also enhance service effectiveness and efficiency.
Advanced nurse roles in UK primary care.
Sibbald B, Laurant MG, Reeves D
Med J Aust. 2006 Jul 3;185(1):10-2.
Nurses increasingly work as substitutes for, or to complement, general practitioners in the care of minor illness and the management of chronic diseases. Available research suggests that nurses can provide as high quality care as GPs in the provision of first contact and ongoing care for unselected patients. Reductions in cost are context dependent and rarely achieved. This is because savings on nurses' salaries are often offset by their lower productivity (due to longer consultations, higher patient recall rates, and increased use of tests and investigations). Gains in efficiency are not achieved when GPs continue to provide the services that have been delegated to nurses, instead of focusing on the services that only doctors can provide. Unintended consequences of extending nursing roles include loss of personal continuity of care for patients and increased difficulties with coordination of care as the multidisciplinary team size increases. Rapid access to care is, however, improved. There is a high capital cost involved in moving to multidisciplinary teams because of the need to train staff in new ways of working; revise legislation governing scope of practice; address concerns about legal liability; and manage professional resistance to change. Despite the unintended consequences and the high costs, extending nursing roles in primary care is a plausible strategy for improving service capacity without compromising quality of care or health outcomes for patients.
Physician assistants and nurse practitioners: the United States experience.
Med J Aust. 2006 Jul 3;185(1):4-7.
Physician assistants (PAs) and nurse practitioners (NPs) were introduced in the United States in 1967. As of 2006, there are 110 000 clinically active PAs and NPs (comprising approximately one sixth of the US medical workforce). Approximately 11 200 new PAs and NPs graduate each year. PAs and NPs are well distributed throughout primary care and specialty care and are more likely than physicians to practise in rural areas and where vulnerable populations exist. The productivity of NPs and PAs, based on traditional doctor services, is comparable, and the range of services approaches 90% of what primary care physicians provide. The education time is approximately half that of a medical doctor and entry into the workforce is less restrictive. The interprofessional skill mix provided by PAs and NPs may enhance medical care in comparison with that provided by a doctor alone.
Consent in surgery.
Ann R Coll Surg Engl. 2006 May;88(3):261-4.
A review of consent for surgery is timely. As the length of surgeons' training diminishes, despite the increasing interest in the content of the surgical curriculum, the law governing the process of gaining consent has been given scant attention. The advent of non-medically qualified surgical practitioners raises questions about the breadth of knowledge that is required to ensure that valid consent is obtained. Consent is as fundamental as any other basic principle on which surgical practice relies, and its use in patient care is a clinical skill.The 'traditional' approach to consent contained some negative elements. A doctor who was incapable of performing the proposed operation often obtained consent. In a genuine attempt to protect patients from anxiety, the rare-but-grave potential complications were sometimes not discussed. There was uncertainty about what should properly be disclosed, compounded by conflicting messages from the courts. The consent was sometimes taken from people who were ineligible to provide it.These could be viewed as aberrations, and some persist. Having clarified the necessity for consent, this review concludes that it should be obtained by the operating surgeon. The threshold for interventions that need formal consent is discussed, together with the legal tests for capacity. In considering the recent law, it becomes clear that any potential complication that the reasonable patient would need to take into consideration before deciding to give their consent is one that should be disclosed.
[Abdominal compartment syndrome.]
Bertram P, Schachtrupp A, Rosch R, Schumacher O, Schumpelick V
Chirurg. 2006 May 20;.
Abdominal compartment syndrome (ACS) is characterized by a persistent pathologic increase in intra-abdominal pressure (IAP) exceeding 20 mmHg with consecutive dysfunction of multiple organ systems. The main causes of ACS are abdominal trauma, obstruction, infection, and sepsis, but it may also be initiated by extra-abdominal diseases. The gold standard for diagnosis is repeated assessment of the IAP measurements of bladder pressure. The incidence of ACS is up to 15% in operative ICUs and the therapy of choice for it is decompressive laparotomy. Nevertheless, mortality is high, up to 60%.
[Responsibility of surgeons for surgical site infections.]
Gastmeier P, Brandt C, Sohr D, Ruden H
Chirurg. 2006 May 17;.
Surgical site infections can be traced to discrepancies in one specific hospital department: the operating suite. Therefore, prevention is often viewed as resting completely on the surgeon. However, the source of micro-organisms responsible for surgical site infections can be endogenous or exogenous. Most infections are believed to be the former, i.e. caused by micro-organisms already resident in the patient's body. Therefore the surgeon can be regarded as suspect only in exceptional cases and usually himself a victim. Prevention is possible not only for exogenous surgical site infection but also many endogenous infections. A multicenter surveillance of infection rates at 130 operative departments participating for at least 4 years in the German National Nosocomial Infection Surveillance System was conducted. A significant 25% reduction in the 3rd year was observed compared with patients who underwent surgery within the 1st year of participation. However, surgeons alone cannot achieve such a decrease, and a team approach is required under most circumstances.
In Reappraisal of the Bidet, Nearly Half a Century Later.
Dis Colon Rectum. 2006 May 11;.
Second-order peer review of the medical literature for clinical practitioners.
Haynes RB, Cotoi C, Holland J, Walters L, Wilczynski N, Jedraszewski D, McKinlay J, Parrish R, McKibbon KA
JAMA. 2006 Apr 19;295(15):1801-8.
CONTEXT: Most articles in clinical journals are not appropriate for direct application by individual clinicians. OBJECTIVE: To create a second order of clinical peer review for journal articles to determine which articles are most relevant for specific clinical disciplines. DESIGN AND SETTING: A 2-stage prospective observational study in which research staff reviewed all issues of over 110 (number has varied slightly as new journals were added or discarded from review but number has always been over 110) clinical journals and selected each article that met critical appraisal criteria from January 2003 through the present. Practicing physicians were recruited from around the world, excluding Northern Ontario, to the McMaster Online Rating of Evidence (MORE) system and registered as raters according to their clinical disciplines. An automated system assigned each qualifying article to raters for each pertinent clinical discipline, and recorded their online assessments of the articles on 7-point scales (highest score, 7) of relevance and newsworthiness (defined as useful new information for physicians). Rated articles fed an online alerting service, the McMaster Premium Literature Service (PLUS). Physicians from Northern Ontario were invited to register with PLUS and then receive e-mail alerts about articles according to MORE system peer ratings for their own discipline. Online access by PLUS users of PLUS alerts, raters' comments, article abstracts, and full-text journal articles was automatically recorded. MAIN OUTCOME MEASURES: Clinical rater recruitment and performance. Relevance and newsworthiness of journal articles to clinical practice in the discipline of the rating physician. RESULTS: Through October 2005, MORE had 2139 clinical raters, and PLUS had 5892 articles with 45 462 relevance ratings and 44 724 newsworthiness ratings collected since 2003. On average, clinicians rated systematic review articles higher for relevance to practice than articles with original evidence and lower for useful new information. Primary care physicians rated articles lower than did specialists (P<.05). Of the 98 physicians who registered for PLUS, 88 (90%) used it on 3136 occasions during an 18-month test period. CONCLUSIONS: This demonstration project shows the feasibility and use of a post-publication clinical peer review system that differentiates published journal articles according to the interests of a broad range of clinical disciplines.
Women in surgery: do we really understand the deterrents?
Gargiulo DA, Hyman NH, Hebert JC
Arch Surg. 2006 Apr;141(4):405-7; discussion 407-8.
HYPOTHESIS: Women are deterred from a surgical career owing to a lack of role models rather than lifestyle considerations. DESIGN: Survey. SETTING: University teaching hospital. PARTICIPANTS: Surgery and obstetrics/gynecology attending physicians, residents, and medical students. INTERVENTION: Questionnaire. MAIN OUTCOME MEASURES: Potential deterrents to a surgical career. RESULTS: Men and women had a similar interest in a surgical career before their surgical rotation (64% vs 53%, P = .68). A similar percentage developed a mentor (40.0% vs 45.9%, P = .40). Women were far more likely to perceive sex discrimination (46.7% vs 20.4%, P = .002), most often from male attending physicians (33.3%) or residents (31.1%). Women were less likely to be deterred by diminishing rewards (4.4% vs 21.6%, P = .003) or workload considerations (28.9% vs 49.0%, P = .02). They were also less likely to cite family concerns as a deterrent (47.8% vs 66.7%, P = .02) and equally likely to be deterred by lifestyle during residency (83.3% vs 76.5%, P = .22). However, women were more likely to be deterred by perceptions of the "surgical personality" (40.0% vs 21.6%, P = .03) and the perception of surgery as an "old boys' club" (22.2% vs 3.9%, P = .002). CONCLUSIONS: Men and women are very similar in what they consider important in deciding on a surgical career. Women are not more likely to be deterred by lifestyle, workload issues, or lack of role models. However, the perceived surgical personality and surgical culture is a sex-specific deterrence to a career in surgery for women.
Incidence, patterns, and prevention of wrong-site surgery.
Kwaan MR, Studdert DM, Zinner MJ, Gawande AA
Arch Surg. 2006 Apr;141(4):353-7; discussion 357-8.
HYPOTHESIS: We hypothesized that wrong-site surgery is infrequent and that a substantial proportion of such incidents are not preventable by current site-verification protocols. DESIGN: Case series and survey of site-verification protocols. SETTING: Hospitals and a malpractice liability insurer. PATIENTS AND OTHER PARTICIPANTS: All wrong-site surgery cases reported to a large malpractice insurer between 1985 and 2004. MAIN OUTCOME MEASURES: Incidence, characteristics, and causes of wrong-site surgery and characteristics of site-verification protocols. RESULTS: Among 2,826,367 operations at insured institutions during the study period, 25 nonspine wrong-site operations were identified, producing an incidence of 1 in 112,994 operations (95% confidence interval, 1 in 76,336 to 1 in 174,825). Medical records were available for review in 13 cases. Among reviewed claims, patient injury was permanent-significant in 1, temporary-major in 2, and temporary-minor or temporary-insignificant in 10. Under optimal conditions, the Joint Commission on Accreditation of Healthcare Organizations Universal Protocol might have prevented 8 (62%) of 13 cases. Hospital protocol design varied significantly. The protocols mandated 2 to 4 personnel to perform 12 separate operative-site checks on average (range, 5-20). Five protocols required site marking in cases that involved nonmidline organs or structures; 6 required it in all cases. CONCLUSIONS: Wrong-site surgery is unacceptable but exceedingly rare, and major injury from wrong-site surgery is even rarer. Current site-verification protocols could have prevented only two thirds of the examined cases. Many protocols involve considerable complexity without clear added benefit.
Patient Safety in Surgery.
Makary MA, Sexton JB, Freischlag JA, Millman EA, Pryor D, Holzmueller C, Pronovost PJ
Ann Surg. 2006 May;243(5):628-635.
BACKGROUND:: Improving patient safety is an increasing priority for surgeons and hospitals since sentinel events can be catastrophic for patients, caregivers, and institutions. Patient safety initiatives aimed at creating a safe operating room (OR) culture are increasingly being adopted, but a reliable means of measuring their impact on front-line providers does not exist. METHODS:: We developed a surgery-specific safety questionnaire (SAQ) and administered it to 2769 eligible caregivers at 60 hospitals. Survey questions included the appropriateness of handling medical errors, knowledge of reporting systems, and perceptions of safety in the operating room. MANOVA and ANOVA were performed to compare safety results by hospital and by an individual's position in the OR using a composite score. Multilevel confirmatory factor analysis was performed to validate the structure of the scale at the operating room level of analysis. RESULTS:: The overall response rate was 77.1% (2135 of 2769), with a range of 57% to 100%. Factor analysis of the survey items demonstrated high face validity and internal consistency (alpha = 0.76). The safety climate scale was robust and internally consistent overall and across positions. Scores varied widely by hospital [MANOVA omnibus F (59, 1910) = 3.85, P < 0.001], but not position [ANOVA F (4, 1910) = 1.64, P = 0.16], surgeon (mean = 73.91), technician (mean = 70.26), anesthesiologist (mean = 71.57), CRNA (mean = 71.03), and nurse (mean = 70.40). The percent of respondents reporting good safety climate in each hospital ranged from 16.3% to 100%. CONCLUSIONS:: Safety climate in surgical departments can be validly measured and varies widely among hospitals, providing the opportunity to benchmark performance. Scores on the SAQ can serve to evaluate interventions to improve patient safety.
Transparent and open discussion of errors does not increase malpractice risk in trauma patients.
Stewart RM, Corneille MG, Johnston J, Geoghegan K, Myers JG, Dent DL, McFarland M, Alley J, Pruitt BA Jr, Cohn SM
Ann Surg. 2006 May;243(5):645-51.
OBJECTIVE:: We set out to determine if there is an increased medical malpractice lawsuit rate when trauma patient cases are presented at an open, multidisciplinary morbidity and mortality conference (M&M). INTRODUCTION:: Patient safety proponents emphasize the importance of transparency with respect to medical errors. In contrast, the tort system focuses on blame and punishment, which encourages secrecy. Our question: Can the goals of the patient safety movement be met without placing care providers and healthcare institutions at unacceptably high malpractice risk? METHODS:: The trauma registry, a risk management database, along with the written minutes of the trauma morbidity and mortality conference (M&M) were used to determine the number and incidence of malpractice suits filed following full discussion at an open M&M conference at an academic level I trauma center. RESULTS:: A total of 20,749 trauma patients were admitted. A total of 412 patients were discussed at M&M conference and a total of seven lawsuits were filed. Six of the patients were not discussed at M&M prior to the lawsuit being filed. One patient was discussed at M&M prior to the lawsuit being filed. The incidence of lawsuit was calculated in three groups: all trauma patients, all trauma patients with complications, and all patients presented at trauma M&M conference. The ratio of lawsuits filed to patients admitted and incidence in the three groups is as follows: All Patients, 7 lawsuits/20,479 patients (4.25 lawsuits/100,000 patients/year); M&M Presentation, 1 lawsuit/421 patients (29.6 lawsuits/100,000 patients/year); All Trauma Complications, 7 lawsuits/6,225 patients (14 lawsuits/100,000 patients/year). Patients with a complication were more likely to sue (P < 0.01); otherwise, there were no statistical differences between groups. CONCLUSIONS:: A transparent discussion of errors, complications, and deaths does not appear to lead to an increased risk of lawsuit.
Effect of 6-month calorie restriction on biomarkers of longevity, metabolic adaptation, and oxidative stress in overweight individuals: a randomized controlled trial.
Heilbronn LK, de Jonge L, Frisard MI, DeLany JP, Larson-Meyer DE, Rood J, Nguyen T, Martin CK, Volaufova J, Most MM, Greenway FL, Smith SR, Deutsch WA, Williamson DA, Ravussin E
JAMA. 2006 Apr 5;295(13):1539-48.
CONTEXT: Prolonged calorie restriction increases life span in rodents. Whether prolonged calorie restriction affects biomarkers of longevity or markers of oxidative stress, or reduces metabolic rate beyond that expected from reduced metabolic mass, has not been investigated in humans. OBJECTIVE: To examine the effects of 6 months of calorie restriction, with or without exercise, in overweight, nonobese (body mass index, 25 to <30) men and women. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial of healthy, sedentary men and women (N = 48) conducted between March 2002 and August 2004 at a research center in Baton Rouge, La. INTERVENTION: Participants were randomized to 1 of 4 groups for 6 months: control (weight maintenance diet); calorie restriction (25% calorie restriction of baseline energy requirements); calorie restriction with exercise (12.5% calorie restriction plus 12.5% increase in energy expenditure by structured exercise); very low-calorie diet (890 kcal/d until 15% weight reduction, followed by a weight maintenance diet). MAIN OUTCOME MEASURES: Body composition; dehydroepiandrosterone sulfate (DHEAS), glucose, and insulin levels; protein carbonyls; DNA damage; 24-hour energy expenditure; and core body temperature. RESULTS: Mean (SEM) weight change at 6 months in the 4 groups was as follows: controls, -1.0% (1.1%); calorie restriction, -10.4% (0.9%); calorie restriction with exercise, -10.0% (0.8%); and very low-calorie diet, -13.9% (0.7%). At 6 months, fasting insulin levels were significantly reduced from baseline in the intervention groups (all P<.01), whereas DHEAS and glucose levels were unchanged. Core body temperature was reduced in the calorie restriction and calorie restriction with exercise groups (both P<.05). After adjustment for changes in body composition, sedentary 24-hour energy expenditure was unchanged in controls, but decreased in the calorie restriction (-135 kcal/d [42 kcal/d]), calorie restriction with exercise (-117 kcal/d [52 kcal/d]), and very low-calorie diet (-125 kcal/d [35 kcal/d]) groups (all P<.008). These "metabolic adaptations" (~ 6% more than expected based on loss of metabolic mass) were statistically different from controls (P<.05). Protein carbonyl concentrations were not changed from baseline to month 6 in any group, whereas DNA damage was also reduced from baseline in all intervention groups (P <.005). CONCLUSIONS: Our findings suggest that 2 biomarkers of longevity (fasting insulin level and body temperature) are decreased by prolonged calorie restriction in humans and support the theory that metabolic rate is reduced beyond the level expected from reduced metabolic body mass. Studies of longer duration are required to determine if calorie restriction attenuates the aging process in humans. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00099151.
A trial of disclosing physicians' financial incentives to patients.
Pearson SD, Kleinman K, Rusinak D, Levinson W
Arch Intern Med. 2006 Mar 27;166(6):623-8.
BACKGROUND: Concern regarding financial conflict of interest for physicians has led to calls for disclosure of financial incentives to patients. However, limited data on the outcomes of disclosure exist to guide policy. METHODS: This randomized trial was conducted among 8000 adult patients at 2 multispecialty group practices based in the Boston, Mass, and Los Angeles, Calif, areas. Intervention patients were mailed a compensation disclosure letter written by the chief medical officer of their physician group, and all patients were surveyed approximately 3 months later. RESULTS: Disclosure patients were significantly more able to identify correctly the compensation model of their primary care physician, in Boston (adjusted odds ratio, 2.30; 95% confidence interval, 1.92-2.75) and in Los Angeles (adjusted odds ratio, 1.37; 95% confidence interval, 1.03-1.82). Disclosure patients also had more confidence in their ability to judge the possible influence of incentives on their health care: in Boston, 32.5% vs 17.8% (P<.001); and in Los Angeles, 31.8% vs 26.4% (P = .20). The disclosure intervention did not change trust in primary care physicians overall. However, of patients who remembered receiving the disclosure, 21.4% in Boston and 24.4% in Los Angeles responded that the disclosure had increased trust either greatly or somewhat, while in both cities less than 5% of patients responded that the information decreased trust. Patients' loyalty to their physician group was higher among disclosure patients in Boston (73.4% vs 70.2%; P = .03) and Los Angeles (74.1% vs 66.9%; P = .08). CONCLUSIONS: Among diverse patient populations, a single mailed disclosure letter from physician groups was associated with improved knowledge of physicians' compensation models. Patients' trust in their physicians was unharmed, and their loyalty to their physician group was strengthened. For physician groups with similar compensation programs, disclosure to patients should be considered an effective method to enhance the patient-physician relationship.
Surgical skills and lessons from other vocations: a personal view.
Ann R Coll Surg Engl. 2006 Mar;88(2):95-8.
Formerly, a few lucky trainees, attached to talented masters* keen to teach, derived excellent, well-rounded training - but many others struggled alone. Now, formal courses allow experts to teach simple, safe methods, often using simulations. Courses are usually delivered as modules - each unit designed to provide an assessable competence. Simulations are, however, imperfect substitutes for living tissues. Such courses are aids, not substitutes, for operative experience - but this, for many irreversible reasons, is restricted.Successful operators in all specialties and all countries, have in common the combination of good judgement, commitment, intimate knowledge of anatomy and pathology, together with technical skills that are more easily recognised than described. We need to identify good trainers and relieve them of commitments that reduce their ability to pass on their skills. As a trainee, try to identify and copy their characteristics. This advice comes not from a gifted surgeon but from one fortunate to have worked with, and watched, surgical masters - and who is still privileged to teach.
Relations between physicians and attorneys.
JAMA. 2006 Apr 12;295(14):1643.
Prevalence of overweight and obesity in the United States, 1999-2004.
Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM
JAMA. 2006 Apr 5;295(13):1549-55.
CONTEXT: The prevalence of overweight in children and adolescents and obesity in adults in the United States has increased over several decades. OBJECTIVE: To provide current estimates of the prevalence and trends of overweight in children and adolescents and obesity in adults. DESIGN, SETTING, AND PARTICIPANTS: Analysis of height and weight measurements from 3958 children and adolescents aged 2 to 19 years and 4431 adults aged 20 years or older obtained in 2003-2004 as part of the National Health and Nutrition Examination Survey (NHANES), a nationally representative sample of the US population. Data from the NHANES obtained in 1999-2000 and in 2001-2002 were compared with data from 2003-2004. MAIN OUTCOME MEASURES: Estimates of the prevalence of overweight in children and adolescents and obesity in adults. Overweight among children and adolescents was defined as at or above the 95th percentile of the sex-specific body mass index (BMI) for age growth charts. Obesity among adults was defined as a BMI of 30 or higher; extreme obesity was defined as a BMI of 40 or higher. RESULTS: In 2003-2004, 17.1% of US children and adolescents were overweight and 32.2% of adults were obese. Tests for trend were significant for male and female children and adolescents, indicating an increase in the prevalence of overweight in female children and adolescents from 13.8% in 1999-2000 to 16.0% in 2003-2004 and an increase in the prevalence of overweight in male children and adolescents from 14.0% to 18.2%. Among men, the prevalence of obesity increased significantly between 1999-2000 (27.5%) and 2003-2004 (31.1%). Among women, no significant increase in obesity was observed between 1999-2000 (33.4%) and 2003-2004 (33.2%). The prevalence of extreme obesity (body mass index > or =40) in 2003-2004 was 2.8% in men and 6.9% in women. In 2003-2004, significant differences in obesity prevalence remained by race/ethnicity and by age. Approximately 30% of non-Hispanic white adults were obese as were 45.0% of non-Hispanic black adults and 36.8% of Mexican Americans. Among adults aged 20 to 39 years, 28.5% were obese while 36.8% of adults aged 40 to 59 years and 31.0% of those aged 60 years or older were obese in 2003-2004. CONCLUSIONS: The prevalence of overweight among children and adolescents and obesity among men increased significantly during the 6-year period from 1999 to 2004; among women, no overall increases in the prevalence of obesity were observed. These estimates were based on a 6-year period and suggest that the increases in body weight are continuing in men and in children and adolescents while they may be leveling off in women.
Origin and funding of the most frequently cited papers in medicine: database analysis.
Patsopoulos NA, Analatos AA, Ioannidis JP
BMJ. 2006 Mar 17;.
OBJECTIVE: To evaluate changes in the role of academics and the sources of funding for the medical research cited most frequently over the past decade. DESIGN: Database analysis. DATA SOURCES: Web of Knowledge database. METHODS: For each year from 1994 to 2003, articles in the domain of clinical medicine that had been cited most often by the end of 2004 were identified. Changes in authors' affiliations and funding sources were evaluated. RESULTS: Of the 289 frequently cited articles, most had at least one author with a university (76%) or hospital (57%) affiliation, and the proportion of articles with each type of affiliation was constant over time. Government or public funding was most common (60% of articles), followed by industry (36%). The proportion of most frequently cited articles funded by industry increased over time (odds ratio 1.17 per year, P=0.001) and was equal to the proportion funded by government or public sources by 2001. 65 of the 77 most cited randomised controlled trials received funding from industry, and the proportion increased significantly over time (odds ratio 1.59 per year, P=0.003). 18 of the 32 most cited trials published after 1999 were funded by industry alone. CONCLUSION: Academic affiliations remain prominent among the authors of the most frequently cited medical research. Such research is increasingly funded by industry, often exclusively so. Academics may be losing control of the clinical research agenda.
Health benefits of physical activity: the evidence.
Warburton DE, Nicol CW, Bredin SS
CMAJ. 2006 Mar 14;174(6):801-9.
The primary purpose of this narrative review was to evaluate the current literature and to provide further insight into the role physical inactivity plays in the development of chronic disease and premature death. We confirm that there is irrefutable evidence of the effectiveness of regular physical activity in the primary and secondary prevention of several chronic diseases (e.g., cardiovascular disease, diabetes, cancer, hypertension, obesity, depression and osteoporosis) and premature death. We also reveal that the current Health Canada physical activity guidelines are sufficient to elicit health benefits, especially in previously sedentary people. There appears to be a linear relation between physical activity and health status, such that a further increase in physical activity and fitness will lead to additional improvements in health status.
The need for randomised controlled trials in urogynaecology.
Maher C, Schuessler B
Int Urogynecol J Pelvic Floor Dysfunct. 2006 Mar 31;.
[Reasons for the choice of urology by residents]
Bruyere F, d'Arcier BF, Lanson Y
Prog Urol. 2005 Sep;15(4):681-3.
OBJECTIVE: Due to the reduction of the potential number of residents in surgery, a study was conducted to determine the reasons motivating the choice of urology. MATERIAL AND METHODS: A questionnaire was sent to several generations of urologists concerning the criteria which influenced their choice of this surgical subspecialty. RESULTS: More than one half had chosen urology before their residency. Almost none of the urologists in this subgroup hesitated about another surgical subspecialty at the time of their final choice. Hospital medical training is therefore an essential factor in the choice of the future specialty. Almost all urologists who chose their specialty during their residency initially hesitated with another discipline, corresponding to gastrointestinal surgery in 59% of cases. The most attractive feature was the medical and surgical aspect of urology and possibility of group practice with several urologists, limiting the time on call. CONCLUSIONS: Hospital medical students therefore constitute a potential reserve for urologists and need to be motivated by means of good quality practical teaching. Residents in other specialties can also modify their initial choice in favour of urology, especially gastrointestinal surgeons.
Current and future challenges facing academic medicine.
Int Urogynecol J Pelvic Floor Dysfunct. 2006 Feb 17;.
Interactive biomaterials: taking surgery to the next level.
Hiles M, Levitsky S
Int Surg. 2005 Jul-Aug;90(3 Suppl):S13-20.
Medicine has been advanced greatly by implantable biomaterials, but today's standard materials are not without problems. Infection, erosion, adhesions, persistent pain, and other complications suggest that something better is possible. Just as normal tissues self-renew, it is desirable to have an implant recapitulate original anatomy for both structure and function. Short of complete tissue regeneration, perhaps an implant material could transition from an inanimate bridge to a living tissue with strong similarity to the original host architecture-to optimize the biology and not simply the mechanics of tissue repair. Such remodelable or tissue-inductive materials exist today and are in use in a wide variety of surgical applications. Changing the idea that implants must be rigid, inert, and permanent to an understanding that implants can provide short-term mechanics and long-term repair by harnessing the host's healing abilities represents a paradigm shift that will ultimately benefit patients and the practice of surgery.
Are meshes with lightweight construction strong enough?
Int Surg. 2005 Jul-Aug;90(3 Suppl):S10-2.
The use of mesh has become essential in the repair of abdominal wall incisional hernias. Suture techniques, reapplied after failure of a primary repair, are characterized by recurrence rates of up to 50 percent, whereas the reinforcement of the abdominal wall with surgical mesh has significantly decreased these rates to <10 percent. This article describes the background for the development of mesh with lightweight construction and physiological biomechanical performance.
Surgical adhesion development and prevention.
Int Surg. 2005 Jul-Aug;90(3 Suppl):S6-9.
Health industry practices that create conflicts of interest: a policy proposal for academic medical centers.
Brennan TA, Rothman DJ, Blank L, Blumenthal D, Chimonas SC, Cohen JJ, Goldman J, Kassirer JP, Kimball H, Naughton J, Smelser N
JAMA. 2006 Jan 25;295(4):429-33.
Conflicts of interest between physicians' commitment to patient care and the desire of pharmaceutical companies and their representatives to sell their products pose challenges to the principles of medical professionalism. These conflicts occur when physicians have motives or are in situations for which reasonable observers could conclude that the moral requirements of the physician's roles are or will be compromised. Although physician groups, the manufacturers, and the federal government have instituted self-regulation of marketing, research in the psychology and social science of gift receipt and giving indicates that current controls will not satisfactorily protect the interests of patients. More stringent regulation is necessary, including the elimination or modification of common practices related to small gifts, pharmaceutical samples, continuing medical education, funds for physician travel, speakers bureaus, ghostwriting, and consulting and research contracts. We propose a policy under which academic medical centers would take the lead in eliminating the conflicts of interest that still characterize the relationship between physicians and the health care industry.
Guidelines for Interactions between Clinical Faculty and the Pharmaceutical Industry: One Medical School's Approach.
Coleman DL, Kazdin AE, Miller LA, Morrow JS, Udelsman R
Acad Med. 2006 Feb;81(2):154-60.
A productive and ethical relationship between the pharmaceutical industry and physicians is critical to improving drug discovery and public health. In response to concerns about inappropriate financial relationships between the pharmaceutical industry and physicians, national organizations representing physicians or industry have made recommendations designed to reduce conflicts of interest, legal exposure, and dissemination of biased information. Despite these initiatives, the prescribing practices of physicians may be unduly influenced by the marketing efforts of industry and physicians may inadvertently distribute information that is biased in favor of a commercial entity. Moreover, physicians may be vulnerable to prosecution through federal anti-kickback and false claims statutes because of potentially inappropriate financial relationships with pharmaceutical companies. Since academic medical centers have a critical role in establishing professional standards, the faculty of Yale University School of Medicine developed guidelines for the relationships of faculty with the pharmaceutical industry, which were approved in May 2005. Input from clinical faculty and from representatives of the pharmaceutical industry was utilized in formulating the guidelines. In contrast to existing recommendations, the Yale guidelines, which are presented as an Appendix here, ban faculty from receiving any form of gift, meal, or free drug sample (for personal use) from industry, and set more stringent standards for the disclosure and resolution of financial conflict of interest in Yale's educational programs. The growing opportunities for drug discovery, the need to use medications in a more evidence-based manner, and preservation of the public trust require the highest professional standards of rigor and integrity. These guidelines are offered as part of the strategy to meet this compelling challenge.
A program to provide regulatory support for investigator-initiated clinical research.
Arbit HM, Paller MS
Acad Med. 2006 Feb;81(2):146-53.
Investigator-initiated clinical trials represent a small but extremely important portion of medical research. In the process of translating basic science discoveries to novel therapies, new drugs or devices may be developed and tested. In light of increased compliance scrutiny, the need to streamline research projects, and the growing complexity of the U.S. Food and Drug Administration's (FDA's) regulations, the research leadership at the University of Minnesota Academic Health Center (AHC) determined in 2002 that a service should be established to address these issues. The assumption was that providing a service to assist researchers with regulatory obligations would result in additional clinical research that might not have been pursued due to perceived regulatory hurdles. The authors present an overview of the FDA regulatory process as it applies to investigator-initiated research involving investigational new drugs and investigational medical devices. The rationale for creating a program designed specifically to assist faculty with investigational new drug (IND) applications and investigational device exemption (IDE) applications is discussed. The services provided by the IND/IDE Assistance Program (IAP) at the University of Minnesota Academic Health Center are described. The value of the IAP to the AHC is presented along with examples of successes attributable to the IAP and lessons learned so far. Since the establishment of the IAP several issues that might have placed the university at risk have been identified. These issues have been addressed to help improve the ease in which investigator-initiated research is conducted and compliance is maintained.
Differences in review quality and recommendations for publication between peer reviewers suggested by authors or by editors.
Schroter S, Tite L, Hutchings A, Black N
JAMA. 2006 Jan 18;295(3):314-7.
CONTEXT: Many journals give authors who submit papers the opportunity to suggest reviewers. Use of these reviewers varies by journal and little is known about the quality of the reviews they produce. OBJECTIVE: To compare author- and editor-suggested reviewers to investigate differences in review quality and recommendations for publication. DESIGN, SETTING, AND PARTICIPANTS: Observational study of original research papers sent for external review at 10 biomedical journals. Editors were instructed to make decisions about their choice of reviewers in their usual manner. Journal administrators then requested additional reviews from the author's list of suggestions according to a strict protocol. MAIN OUTCOME MEASURE: Review quality using the Review Quality Instrument and the proportion of reviewers recommending acceptance (including minor revision), revision, or rejection. RESULTS: There were 788 reviews for 329 manuscripts. Review quality (mean difference in Review Quality Instrument score, -0.05; P = .27) did not differ significantly between author- and editor-suggested reviewers. The author-suggested reviewers were more likely to recommend acceptance (odds ratio, 1.64; 95% confidence interval, 1.02-2.66) or revise (odds ratio, 2.66; 95% confidence interval, 1.43-4.97). This difference was larger in the open reviews of BMJ than among the blinded reviews of other journals for acceptance (P = .02). Where author- and editor-suggested reviewers differed in their recommendations, the final editorial decision to accept or reject a study was evenly balanced (50.9% of decisions consistent with the preferences of the author-suggested reviewers). CONCLUSIONS: Author- and editor-suggested reviewers did not differ in the quality of their reviews, but author-suggested reviewers tended to make more favorable recommendations for publication. Editors can be confident that reviewers suggested by authors will complete adequate reviews of manuscripts, but should be cautious about relying on their recommendations for publication.
Propensity scores and the surgeon.
Adamina M, Guller U, Weber WP, Oertli D
Br J Surg. 2006 Jan 9;.
BACKGROUND:: Evidence-based surgery has been established as a cornerstone of good clinical practice, promising to improve the treatment of patients and the quality of surgical education. However, evidence-based surgery requires dedicated clinicians trained to perform methodologically sound clinical investigations. Statistical knowledge is therefore invaluable. Surgical studies often cannot be randomized. Propensity scores offer a powerful alternative to multivariable analysis in the assessment of observational, non-randomized surgical studies. Unfortunately, many surgeons are unaware of this important analytical approach that has gained increasing stature in medical research. Thus, propensity score analyses are not used often in surgical studies. OBJECTIVE:: The purpose of this paper is to provide a comprehensive overview of propensity score analysis, allowing the surgeon to understand the role, advantages and limitations of propensity scores, boosting their development in surgical investigations.
Beyond the myth: The mermaid syndrome from Homerus to Andersen A tribute to Hans Christian Andersen's bicentennial of birth.
Romano S, Esposito V, Fonda C, Russo A, Grassi R
Eur J Radiol. 2006 Jan 16;.
Mermaid or sirens have been part of the cultural tradition of the sailors during the first expeditions in the western world. The Siren's Myth appeared for a first time with Homer, who described in the Odyssey some singing creatures that lured the enchanted sailors to death. More frequently described with a bird body and a female head, sometimes the female part was extended to torso, with arms prolonged in sturdy claws. In the Latin literature Publius Ovidius Naso presented in the Metamorphoses these creatures. Proposed ethimology for the word "siren" seems to confirm the prerogatives of these creatures, related to magnetism, seduction, charm. The first figuration of Sirens resembling to fish-women was in the second century bc. Hans Christian Andersen provided to leave us the strongest legend of Siren in the well-known fairy tale "The Little Mermaid". Following this story, Sirens are definitely considered as beautiful half-fish women who lived in the bottom of the sea, having a lovely voice to be used when they rise up to allow sweeter the agony of the wrecked sailors. Beyond the Myth, may the Siren really exist? It can be hypothesized that these creatures probably were individuals affected by sirenomelia. In our literature and medical review, we describe the etiology of the disease, and we illustrated the anatomical features of fetuses affected by this pathology using MDCT 3D reconstructions. Syrenomelia is a condition not compatible with the normal life, however nine cases of "mermaid" survived to reconstructive surgery have been reported until now. In our report we also presented a case of survival baby girl affected by sirenomelia, before and after surgery, with correlative radiologic imaging findings. The most important characteristic that seems to allow survival of the affected individuals is the presence of one functional kidney, displaced in pelvis. As so dramatically tragic was the history Andersen Little Mermaid, so unattended pleasant would be the destiny of a modern mermaid, who can hope to finally marry her prince, without the risk to of the "loose her head", as the Copenhagen City's Symbol did in the past years, for a story beyond the Myth.
Sacral neuromodulation: long-term experience of one center.
J Urol. 2006 Feb;175(2):632.