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1.  Interactions between Non-Physician Clinicians and Industry: A Systematic Review 
PLoS Medicine  2013;10(11):e1001561.
In a systematic review of studies of interactions between non-physician clinicians and industry, Quinn Grundy and colleagues found that many of the issues identified for physicians' industry interactions exist for non-physician clinicians.
Please see later in the article for the Editors' Summary
Background
With increasing restrictions placed on physician–industry interactions, industry marketing may target other health professionals. Recent health policy developments confer even greater importance on the decision making of non-physician clinicians. The purpose of this systematic review is to examine the types and implications of non-physician clinician–industry interactions in clinical practice.
Methods and Findings
We searched MEDLINE and Web of Science from January 1, 1946, through June 24, 2013, according to PRISMA guidelines. Non-physician clinicians eligible for inclusion were: Registered Nurses, nurse prescribers, Physician Assistants, pharmacists, dieticians, and physical or occupational therapists; trainee samples were excluded. Fifteen studies met inclusion criteria. Data were synthesized qualitatively into eight outcome domains: nature and frequency of industry interactions; attitudes toward industry; perceived ethical acceptability of interactions; perceived marketing influence; perceived reliability of industry information; preparation for industry interactions; reactions to industry relations policy; and management of industry interactions. Non-physician clinicians reported interacting with the pharmaceutical and infant formula industries. Clinicians across disciplines met with pharmaceutical representatives regularly and relied on them for practice information. Clinicians frequently received industry “information,” attended sponsored “education,” and acted as distributors for similar materials targeted at patients. Clinicians generally regarded this as an ethical use of industry resources, and felt they could detect “promotion” while benefiting from industry “information.” Free samples were among the most approved and common ways that clinicians interacted with industry. Included studies were observational and of varying methodological rigor; thus, these findings may not be generalizable. This review is, however, the first to our knowledge to provide a descriptive analysis of this literature.
Conclusions
Non-physician clinicians' generally positive attitudes toward industry interactions, despite their recognition of issues related to bias, suggest that industry interactions are normalized in clinical practice across non-physician disciplines. Industry relations policy should address all disciplines and be implemented consistently in order to mitigate conflicts of interest and address such interactions' potential to affect patient care.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling health care goods (including drugs and devices) and services is big business. To maximize the profits they make for their shareholders, companies involved in health care build relationships with physicians by providing information on new drugs, organizing educational meetings, providing samples of their products, giving gifts, and holding sponsored events. These relationships help to keep physicians informed about new developments in health care but also create the potential for causing harm to patients and health care systems. These relationships may, for example, result in increased prescription rates of new, heavily marketed medications, which are often more expensive than their generic counterparts (similar unbranded drugs) and that are more likely to be recalled for safety reasons than long-established drugs. They may also affect the provision of health care services. Industry is providing an increasingly large proportion of routine health care services in many countries, so relationships built up with physicians have the potential to influence the commissioning of the services that are central to the treatment and well-being of patients.
Why Was This Study Done?
As a result of concerns about the tension between industry's need to make profits and the ethics underlying professional practice, restrictions are increasingly being placed on physician–industry interactions. In the US, for example, the Physician Payments Sunshine Act now requires US manufacturers of drugs, devices, and medical supplies that participate in federal health care programs to disclose all payments and gifts made to physicians and teaching hospitals. However, other health professionals, including those with authority to prescribe drugs such as pharmacists, Physician Assistants, and nurse practitioners are not covered by this legislation or by similar legislation in other settings, even though the restructuring of health care to prioritize primary care and multidisciplinary care models means that “non-physician clinicians” are becoming more numerous and more involved in decision-making and medication management. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the researchers examine the nature and implications of the interactions between non-physician clinicians and industry.
What Did the Researchers Do and Find?
The researchers identified 15 published studies that examined interactions between non-physician clinicians (Registered Nurses, nurse prescribers, midwives, pharmacists, Physician Assistants, and dieticians) and industry (corporations that produce health care goods and services). They extracted the data from 16 publications (representing 15 different studies) and synthesized them qualitatively (combined the data and reached word-based, rather than numerical, conclusions) into eight outcome domains, including the nature and frequency of interactions, non-physician clinicians' attitudes toward industry, and the perceived ethical acceptability of interactions. In the research the authors identified, non-physician clinicians reported frequent interactions with the pharmaceutical and infant formula industries. Most non-physician clinicians met industry representatives regularly, received gifts and samples, and attended educational events or received educational materials (some of which they distributed to patients). In these studies, non-physician clinicians generally regarded these interactions positively and felt they were an ethical and appropriate use of industry resources. Only a minority of non-physician clinicians felt that marketing influenced their own practice, although a larger percentage felt that their colleagues would be influenced. A sizeable proportion of non-physician clinicians questioned the reliability of industry information, but most were confident that they could detect biased information and therefore rated this information as reliable, valuable, or useful.
What Do These Findings Mean?
These and other findings suggest that non-physician clinicians generally have positive attitudes toward industry interactions but recognize issues related to bias and conflict of interest. Because these findings are based on a small number of studies, most of which were undertaken in the US, they may not be generalizable to other countries. Moreover, they provide no quantitative assessment of the interaction between non-physician clinicians and industry and no information about whether industry interactions affect patient care outcomes. Nevertheless, these findings suggest that industry interactions are normalized (seen as standard) in clinical practice across non-physician disciplines. This normalization creates the potential for serious risks to patients and health care systems. The researchers suggest that it may be unrealistic to expect that non-physician clinicians can be taught individually how to interact with industry ethically or how to detect and avert bias, particularly given the ubiquitous nature of marketing and promotional materials. Instead, they suggest, the environment in which non-physician clinicians practice should be structured to mitigate the potentially harmful effects of interactions with industry.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001561.
This study is further discussed in a PLOS Medicine Perspective by James S. Yeh and Aaron S. Kesselheim
The American Medical Association provides guidance for physicians on interactions with pharmaceutical industry representatives, information about the Physician Payments Sunshine Act, and a toolkit for preparing Physician Payments Sunshine Act reports
The International Council of Nurses provides some guidance on industry interactions in its position statement on nurse-industry relations
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice website, which describes what is required of all registered doctors in the UK
Understanding and Responding to Pharmaceutical Promotion: A Practical Guide is a manual prepared by Health Action International and the World Health Organization that schools of medicine and pharmacy can use to train students how to recognize and respond to pharmaceutical promotion.
The Institute of Medicine's Report on Conflict of Interest in Medical Research, Education, and Practice recommends steps to identify, limit, and manage conflicts of interest
The University of California, San Francisco, Office of Continuing Medical Education offers a course called Marketing of Medicines
doi:10.1371/journal.pmed.1001561
PMCID: PMC3841103  PMID: 24302892
2.  Proceedings of the 2010 Annual Meeting of the Fetal Alcohol Spectrum Disorders Study Group 
Alcohol (Fayetteville, N.y.)  2011;46(1):107-114.
The annual meeting of the Fetal Alcohol Spectrum Disorders Study Group (FASDSG) was held on June 26, 2010 in San Antonio, TX, as a satellite of the Research Society on Alcoholism meeting. The FASDSG membership includes clinical, basic and social scientists who meet to discuss recent advances and issues in FASD research. The central theme of the meeting was “Glia and Neurons: Teamwork in Pathology and Therapy.” Alcohol disruption of neuron development and alcohol-induced neurodegeneration is central to the pathology and clinical expression of FASD. The active role of glia as perpetrator, victim, or bystander in neurotoxicology and neurodegenerative processes has emerged at the forefront of adult CNS disorders and therapy. Glia and neuron-glial interactions hold the potential to elucidate causes and offer treatment of FASD as well. Growing evidence indicates that neurons and glia are direct targets of alcohol, but may also be vulnerable to molecules produced in peripheral systems as a result of alcohol exposure. Diagnostics and therapies can take advantage of these processes and biomarkers, and these may be applicable to CNS pathology in FASD. Two keynote speakers, Howard E. Gendelman, M.D., and Ernest M. Graham, M.D, addressed the role of glia and neuroinflammation in brain development and neurodegeneration. The invited speakers and FASDSG members discussed new paradigms in CNS development and discuss new strategies for understanding and treating neurodegenerative disease. Members of the FASDSG provided updates on new findings through presentation of breaking research in the FASt Data Sessions. Representatives of national agencies provided updates on programs, activities, and funding priorities. The Henry Rosett Award was presented to R. Louise Floyd, R.N., D.S.N. for her career contributions to the field of fetal alcohol research. The Student and Postdoctoral Fellow Research Merit Award was presented to Shonagh O’Leary-Moore, Ph.D. for her contributions to the field as a young investigator.
doi:10.1016/j.alcohol.2011.07.004
PMCID: PMC3258329  PMID: 21889288
3.  Physician Fee Indices in California and the U.S. Through June 1971 Socio-Economic Report of the Bureau of Research and Planning 
California Medicine  1972;116(3):104-107.
California physicians' fees increased 2.2 percent in the first half of 1971, according to figures compiled by the Bureau of Research and Planning. Nationally, physicians' fees increased at a faster rate of 3.4 percent during the same period.
This was the slowest semi-annual increase in the California Index since the final six months of 1968 when fees increased only 2.0 percent. A decline was also recorded in the rate of price increase for other goods and services in the first half of 1971. Nationally, the “all items” increase amounted to 2.0 percent, and the service component rose 2.1 percent.
Also included in this Report is special information on the charging patterns of physicians for office and hospital visits and data on physicians' fees in the Los Angeles and San Francisco Metropolitan Areas.
The California Physician Fee Index is a continuing survey conducted by the CMA Bureau of Research and Planning since 1962. The survey questionnaire which lists 26 medical, surgical, radiological, and laboratory procedures, elicits fee information from approximately 1,000 randomly selected physicians. Since June 1970, the procedures on the questionnaire have been listed according to the coding nomenclature used in the 1969 edition of the Relative Value Studies, published by the California Medical Association. Prior to that, the 1964 edition was used to delineate the procedure being surveyed.
PMCID: PMC1518273  PMID: 5014758
4.  B.M.A. Annual Meeting, Sydney, 10–16 August: Report of Proceedings 
British Medical Journal  1968;3(5616):485-492.
The One Hundred and Thirty-sixth Annual Meeting of the British Medical Association was held in Sydney from 10 to 16 August jointly with the Seventh Annual Meeting of the Australian Medical Association. Both meetings were associated with the Third Australian Medical Congress. It was the second Annual Meeting of the Association to be held in Australia, the previous one having been in Melbourne in 1935. Four plenary sessions were held on successive mornings, while meetings of various sections were held in the afternoons. An account of the first part of the Meeting is given below. The remainder will be reported next week.
Images
PMCID: PMC1986422
5.  Tobacco Company Efforts to Influence the Food and Drug Administration-Commissioned Institute of Medicine Report Clearing the Smoke: An Analysis of Documents Released through Litigation 
PLoS Medicine  2013;10(5):e1001450.
Stanton Glantz and colleagues investigate efforts by tobacco companies to influence Clearing the Smoke, a 2001 Institute of Medicine report on harm reduction tobacco products.
Please see later in the article for the Editors' Summary
Background
Spurred by the creation of potential modified risk tobacco products, the US Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to assess the science base for tobacco “harm reduction,” leading to the 2001 IOM report Clearing the Smoke. The objective of this study was to determine how the tobacco industry organized to try to influence the IOM committee that prepared the report.
Methods and Findings
We analyzed previously secret tobacco industry documents in the University of California, San Francisco Legacy Tobacco Documents Library, and IOM public access files. (A limitation of this method includes the fact that the tobacco companies have withheld some possibly relevant documents.) Tobacco companies considered the IOM report to have high-stakes regulatory implications. They developed and implemented strategies with consulting and legal firms to access the IOM proceedings. When the IOM study staff invited the companies to provide information on exposure and disease markers, clinical trial design for safety and efficacy, and implications for initiation and cessation, tobacco company lawyers, consultants, and in-house regulatory staff shaped presentations from company scientists. Although the available evidence does not permit drawing cause-and-effect conclusions, and the IOM may have come to the same conclusions without the influence of the tobacco industry, the companies were pleased with the final report, particularly the recommendations for a tiered claims system (with separate tiers for exposure and risk, which they believed would ease the process of qualifying for a claim) and license to sell products comparable to existing conventional cigarettes (“substantial equivalence”) without prior regulatory approval. Some principles from the IOM report, including elements of the substantial equivalence recommendation, appear in the 2009 Family Smoking Prevention and Tobacco Control Act.
Conclusions
Tobacco companies strategically interacted with the IOM to win several favored scientific and regulatory recommendations.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Up to half of tobacco users will die of cancer, lung disease, heart disease, stroke, or another tobacco-related disease. Cigarettes and other tobacco products cause disease because they expose their users to nicotine and numerous other toxic chemicals. Tobacco companies have been working to develop a “safe” cigarette for more than half a century. Initially, their attention focused on cigarettes that produced lower tar and nicotine yields in machine-smoking tests. These products were perceived as “safer” products by the public and scientists for many years, but it is now known that the use of low-yield cigarettes can actually expose smokers to higher levels of toxins than standard cigarettes. More recently, the tobacco companies have developed other products (for example, products that heat aerosols of nicotine, rather than burning the tobacco) that claim to reduce harm and the risk of tobacco-related disease, but they can only market these modified risk tobacco products in the US after obtaining Food and Drug Administration (FDA) approval. In 1999, the FDA commissioned the US Institute of Medicine (IOM, an influential source of independent expert advice on medical issues) to assess the science base for tobacco “harm reduction.” In 2001, the IOM published its report Clearing the Smoke: Assessing the Science Base for Tobacco Harm and Reduction, which, although controversial, set the tone for the development and regulation of tobacco products in the US, particularly those claiming to be less dangerous, in subsequent years.
Why Was This Study Done?
Tobacco companies have a long history of working to shape scientific discussions and agendas. For example, they have produced research results designed to “create controversy” about the dangers of smoking and secondhand smoke. In this study, the researchers investigate how tobacco companies organized to try to influence the IOM committee that prepared the Clearing the Smoke report on modified risk tobacco products by analyzing tobacco industry and IOM documents.
What Did the Researchers Do and Find?
The researchers searched the Legacy Tobacco Documents Library (a collection of internal tobacco industry documents released as a result of US litigation cases) for documents outlining how tobacco companies tried to influence the IOM Committee to Assess the Science Base for Tobacco Harm Reduction and created a timeline of events from the 1,000 or so documents they retrieved. They confirmed and supplemented this timeline using information in 80 files that detailed written interactions between the tobacco companies and the IOM committee, which they obtained through a public records access request. Analysis of these documents indicates that the tobacco companies considered the IOM report to have important regulatory implications, that they developed and implemented strategies with consulting and legal firms to access the IOM proceedings, and that tobacco company lawyers, consultants, and regulatory staff shaped presentations to the IOM committee by company scientists on various aspects of tobacco harm reduction products. The analysis also shows that tobacco companies were pleased with the final report, particularly its recommendation that tobacco products can be marketed with exposure or risk reduction claims provided the products substantially reduce exposure and provided the behavioral and health consequences of these products are determined in post-marketing surveillance and epidemiological studies (“tiered testing”) and its recommendation that, provided no claim of reduced exposure or risk is made, new products comparable to existing conventional cigarettes (“substantial equivalence”) can be marketed without prior regulatory approval.
What Do These Findings Mean?
These findings suggest that tobacco companies used their legal and regulatory staff to access the IOM committee that advised the FDA on modified risk tobacco products and that they used this access to deliver specific, carefully formulated messages designed to serve their business interests. Although these findings provide no evidence that the efforts of tobacco companies influenced the IOM committee in any way, they show that the companies were satisfied with the final IOM report and its recommendations, some of which have policy implications that continue to reverberate today. The researchers therefore call for the FDA and other regulatory bodies to remember that they are dealing with companies with a long history of intentionally misleading the public when assessing the information presented by tobacco companies as part of the regulatory process and to actively protect their public-health policies from the commercial interests of the tobacco industry.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001450.
This study is further discussed in a PLOS Medicine Perspective by Thomas Novotny
The World Health Organization provides information about the dangers of tobacco (in several languages); for information about the tobacco industry's influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
A PLOS Medicine Research Article by Heide Weishaar and colleagues describes tobacco company efforts to undermine the Framework Convention on Tobacco Control, an international instrument for tobacco control
Wikipedia has a page on tobacco harm reduction (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The IOM report Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction is available to read online
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The University of California, San Francisco Center for Tobacco Control Research and Education is the focal point for University of California, San Francisco (UCSF) scientists in disciplines ranging from the molecular biology of nicotine addiction through political science who combine their efforts to eradicate the use of tobacco and tobacco-induced cancer and other diseases worldwide
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking
doi:10.1371/journal.pmed.1001450
PMCID: PMC3665841  PMID: 23723740
6.  IBC’s 23rd Antibody Engineering and 10th Antibody Therapeutics Conferences and the Annual Meeting of The Antibody Society 
mAbs  2012;4(6):648-652.
Now in its 23rd and 10th years, respectively, the Antibody Engineering and Antibody Therapeutics conferences are the Annual Meeting of The Antibody Society. The scientific program covers the full spectrum of challenges in antibody research and development from basic science through clinical development. In this preview of the conferences, the chairs provide their thoughts on sessions that will allow participants to track emerging trends in (1) the development of next-generation immunomodulatory antibodies; (2) the complexity of the environment in which antibodies must function; (3) antibody-targeted central nervous system (CNS) therapies that cross the blood brain barrier; (4) the extension of antibody half-life for improved efficacy and pharmacokinetics (PK)/pharmacodynamics (PD); and (5) the application of next generation DNA sequencing to accelerate antibody research. A pre-conference workshop on Sunday, December 2, 2012 will update participants on recent intellectual property (IP) law changes that affect antibody research, including biosimilar legislation, the America Invents Act and recent court cases.
Keynote presentations will be given by Andreas Plückthun (University of Zürich), who will speak on engineering receptor ligands with powerful cellular responses; Gregory Friberg (Amgen Inc.), who will provide clinical updates of bispecific antibodies; James D. Marks (University of California, San Francisco), who will discuss a systems approach to generating tumor targeting antibodies; Dario Neri (Swiss Federal Institute of Technology Zürich), who will speak about delivering immune modulators at the sites of disease; William M. Pardridge (University of California, Los Angeles), who will discuss delivery across the blood-brain barrier; and Peter Senter (Seattle Genetics, Inc.), who will present his vision for the future of antibody-drug conjugates.
For more information on these meetings or to register to attend, please visit www.IBCLifeSciences.com/AntibodyEng or call 800-390-4078. Members of The Antibody Society and mAbs journal subscribers receive a 20% discount for meeting registration. To obtain this discount, email kdostie@ibcusa.com. mAbs is the official therapeutics journal of The Antibody Society and offers a discounted subscription to Society members for $49.
doi:10.4161/mabs.22221
PMCID: PMC3502231  PMID: 23007482
antibody engineering; antibody therapeutics; antibody-drug conjugates; bispecific antibodies; intellectual property law
7.  Do-not-resuscitate orders and predictive models after intracerebral hemorrhage(e–Pub ahead of print) 
Neurology  2010;75(7):626-633.
Objective:
To quantify the accuracy of commonly used intracerebral hemorrhage (ICH) predictive models in ICH patients with and without early do-not-resuscitate orders (DNR).
Methods:
Spontaneous ICH cases (n = 487) from the Brain Attack Surveillance in Corpus Christi study (2000–2003) and the University of California, San Francisco (June 2001–May 2004) were included. Three models (the ICH Score, the Cincinnati model, and the ICH grading scale [ICH-GS]) were compared to observed 30-day mortality with a χ2 goodness-of-fit test first overall and then stratified by early DNR orders.
Results:
Median age was 71 years, 49% were female, median Glasgow Coma Scale score was 12, median ICH volume was 13 cm3, and 35% had early DNR orders. Overall observed 30-day mortality was 42.7% (95% confidence interval [CI] 38.3–47.1), with the average model-predicted 30-day mortality for the ICH Score, Cincinnati model, and ICH-GS at 39.9% (p = 0.005), 40.4% (p = 0.007), and 53.9% (p < 0.001). However, for patients with early DNR orders, the observed 30-day mortality was 83.5% (95% CI 78.0–89.1), with the models predicting mortality of 64.8% (p < 0.001), 57.2% (p < 0.001), and 77.8% (p = 0.02). For patients without early DNR orders, the observed 30-day mortality was 20.8% (95% CI 16.5–25.7), with the models predicting mortality of 26.6% (p = 0.05), 31.4% (p < 0.001), and 41.1% (p < 0.001).
Conclusions:
ICH prognostic model performance is substantially impacted when stratifying by early DNR status, possibly giving a false sense of model accuracy when DNR status is not considered. Clinicians should be cautious when applying these predictive models to individual patients.
GLOSSARY
= Brain Attack Surveillance in Corpus Christi;
= confidence interval;
= do not resuscitate;
= Glasgow Coma Scale;
= intracerebral hemorrhage;
= intracerebral hemorrhage grading scale;
= receiver operating characteristic;
= San Francisco General Hospital;
= University of California San Francisco.
doi:10.1212/WNL.0b013e3181ed9cc9
PMCID: PMC2931769  PMID: 20610832
8.  Suicide in San Francisco: Reported and Unreported 
California Medicine  1965;102(6):426-430.
Reported suicide in San Francisco was investigated for the period between July 1956, through June 1964. During that time 1664 persons killed themselves, according to the Coroner's records. The method most frequently used was oral ingestion of toxic substances, which significantly deviates from national statistics, shooting being the method most frequently reported. The explanation for this deviation is probably the more valid mortality statistics of San Francisco, and from this it may be inferred that unreported suicide may be largely suicide by ingestion, unrecognized because of lack of postmortem studies.
Unreported suicide is further classified into intentioned (masked, suppressed and undiscovered) and subintentioned (oral-dependent and aggressive).
Despite the fact that suicide has been a leading cause of death, the public and the medical profession are largely apathetic. An attempt is being made by Suicide Prevention of San Francisco, Inc. to develop a clinical and research facility for the study and treatment of suicidal persons.
PMCID: PMC1516172  PMID: 14298870
9.  Consensus Report of the Coalition for Clinical Research—Self-Monitoring of Blood Glucose 
The Coalition for Clinical Research—Self-Monitoring of Blood Glucose Scientific Board, a group of nine academic clinicians and scientists from the United States and Europe, convened in San Francisco, California, on June 11–12, 2008, to discuss the appropriate uses of self-monitoring of blood glucose (SMBG) and the measures necessary to accurately assess the potential benefit of this practice in noninsulin-treated type 2 diabetes mellitus (T2DM). Thirteen consultants from the United States, Europe, and Canada from academia, practice, and government also participated and contributed based on their fields of expertise. These experts represent a range of disciplines that include adult endocrinology, pediatric endocrinology, health education, mathematics, statistics, psychology, nutrition, exercise physiology, and nursing. This coalition was organized by Diabetes Technology Management, Inc. Among the participants, there was consensus that: protocols assessing the performance of SMBG in noninsulin treated T2DM must provide the SMBG intervention subjects with blood glucose (BG) goals and instructions on how to respond to BG data in randomized controlled trials (RCTs);intervention subjects in clinical trials of SMBG-driven interventions must aggressively titrate their therapeutic responses or lifestyle changes in response to hyperglycemia;control subjects in clinical trials of SMBG must be isolated from SMBG-driven interventions and not be contaminated by physician experience with study subjects receiving a SMBG intervention;the best endpoints to measure in a clinical trial of SMBG in T2DM include delta Hemoglobin A1c levels, hyperglycemic events, hypoglycemic events, time to titrate noninsulin therapy to a maximum necessary dosage, and quality of life indices;either individual randomization or cluster randomization may be appropriate methods for separating control subjects from SMBG intervention subjects, provided that precautions are taken to avoid bias and that the sample size is adequate;treatment algorithms for assessing SMBG in T2DM may include a dietary, exercise, and/or medication intervention, which are all titratable according to the SMBG values;the medical literature contains very little information about the performance of SMBG in T2DM from RCTs in which treatment algorithms were used for dysglycemic values; andresearch on the performance of SMBG in T2DM based on sound scientific principles and clinical practices is needed at this time.
PMCID: PMC2769823  PMID: 19885292
consensus; diabetes; glucose; self monitoring; trial; type 2 diabetes
10.  Advances in the biology and therapy of chronic myeloid leukemia (CML): Proceedings from the 6th Post-ASH International CML and Myeloproliferative Neoplasms Workshop 
Leukemia & lymphoma  2012;54(6):1151-1158.
Following the 53rd annual meeting of the American Society of Hematology in San Diego in December 2011, a group of clinical and laboratory investigators convened for the 6th post-ASH International Workshop on chronic myeloid leukemia (CML) and myeloproliferative neoplasms (MPN). The workshop took place on the 13th–14th December at the Estancia, La Jolla, California, USA. This report summarizes the most recent advances in the biology and therapy of CML that were presented at ASH and discussed at the Workshop. Preclinical studies focused on the CML stem cell and its niche, and on early results of deep sequencing of CML genomes. Clinical advances include updates on 2nd and 3rd generation TKIs, molecular monitoring, TKI discontinuation studies, and new therapeutic agents. A report summarizing the pertinent advances in MPN has been published separately.
doi:10.3109/10428194.2012.745524
PMCID: PMC3612371  PMID: 23121619
Chronic myelogenous leukemia; dasatinib; imatinib mesylate; nilotinib; tyrosine kinase inhibitor
11.  Trends in Incidence Rates of Tobacco-Related Cancer, Selected Areas, SEER Program, United States, 1992-2004 
Preventing Chronic Disease  2008;6(1):A16.
Introduction
Recent trends in incidence rates for tobacco-related cancers may vary geographically because of variation in socioeconomic status and in history of comprehensive state tobacco control programs (starting with California in 1989). Recent trends in risk factors are likely to affect cancer incidence rates at the youngest ages.
Methods
Trends in age-adjusted incidence rates for cancers most strongly associated with tobacco (ie, lung, oral cavity-pharynx, and bladder cancers) were analyzed for 1992 through 2004 in 11 areas (the states of Connecticut, Hawaii, Iowa, Utah, and New Mexico, and the metropolitan areas of Atlanta, Georgia; Detroit, Michigan; Los Angeles County, California; San Francisco-Oakland, California; San Jose-Monterey, California; and Seattle-Puget Sound, Washington) in the Surveillance, Epidemiology and End Results (SEER) Program. The 8 states differed in poverty rate of the population and in history of statewide tobacco control efforts as measured by an initial outcomes index (IOI) for the 1990s and a strength of tobacco control (SoTC) index for 1999 through 2000. Annual percentage change (APC) in incidence rate was calculated for whites and blacks separately and by sex for each SEER area.
Results
Among whites, the largest declines for lung cancer were in the 3 SEER areas of California, which were the only areas with significant (negative) APCs for oral cavity-pharynx cancer (but not for bladder cancer). For blacks, significant (negative) APCs for both lung and oral cavity-pharynx cancers were found in 4 of 5 areas with useful data but only 1 of 3 areas for bladder cancer. The strongest correlations of APCs for whites were for lung and oral cavity-pharynx cancers with the IOIs for the early 1990s and with the SoTC (due to the influence of California, which had the highest SoTC).
Conclusion
Lung and oral cavity-pharynx cancer incidence rates among whites aged 15 to 54 years declined more in California than in other areas, possibly because of comprehensive state tobacco control efforts. The different trends for bladder cancer vs other cancers could reflect the influence of risk factors other than tobacco. The greater geographic uniformity of trends among blacks than among whites for lung and oral cavity-pharynx cancers requires further study, particularly in relation to state tobacco control efforts.
PMCID: PMC2644579  PMID: 19080022
12.  Where Do Teens Go to Get the 411 on Sexual Health? A Teen Intern in Clinical Research with Teens 
The Permanente Journal  2008;12(3):47-51.
Research Setting: The research for the study reported here was conducted in conjunction with the Biomedical and Health Sciences Internship for High School Students at the University of California, San Francisco, Department of Pediatrics. The eight-week intensive summer program promotes interest in science, medicine, and health among young people by introducing students to the professional world of science, broadly defined. Interns are expected to assist in a specific research project that addresses a scientific question. They participate in a variety of lectures and are exposed to faculty members, medical students, and college graduates working as research assistants in a rich academic and clinical research setting. This study was conducted within Kaiser Permanente (KP) of Northern California as part of a larger study aimed at increasing Chlamydia screening among sexually active adolescents. It was approved by Committee on Human Research, the institutional review board (IRB) for the University of California, San Francisco and the IRB for KP Northern California.
Objective: There were two primary objectives of this study: first, we sought to identify where teenagers obtain information about sexual health; second, we examined whether aspects of a clinician's communication style with a teen during a health care visit were associated with the teen choosing that clinician as a primary source of sexual health information (as compared with parents, peers, teachers, the news media, and other sources).
Results: Teens who perceived that their clinician communicated with respect and explained information in ways that they could understand were more likely to cite their clinician as a source of sexual health information. Having time alone (confidentiality) with a physician was also associated with teens' selection of a clinician as a primary information source. Whether the clinician asked about sex during the health care visit was significantly associated with males selecting the clinician as a primary source of sexual health information. An important finding, at least for males, because teens do not always bring up the topic.
PMCID: PMC3037124  PMID: 21331209
13.  Proceedings of the 2008 annual meeting of the Fetal Alcohol Spectrum Disorders Study Group 
Alcohol (Fayetteville, N.Y.)  2009;43(4):333-339.
The annual meeting of the Fetal Alcohol Spectrum Disorders Study Group (FASDSG) was held on June 28, 2008 in Washington DC, as a satellite to the Research Society on Alcoholism meeting. The FASDSG membership includes clinical, basic and social scientists, who meet to discuss recent advances and issues in FASD research. The main theme of the meeting was “Factors that Influence Brain and Behavioral Development: Implications for Prevention and Intervention.” Two keynote speakers, Dr. Stephen Suomi and Dr. Carl Keen addressed how early environment and nutrition may influence outcome following prenatal alcohol exposure. The final keynote speaker, Kathy Mitchell, addressed issues regarding the relationship between scientists and the families with children with FASD. Members of the FASDSG provided updates on new findings through brief (FASt) data reports, and national agency representative provided updates of activities and funding priorities. Presentations were also made by recipients of the Student Research Merit award and Rosett award.
doi:10.1016/j.alcohol.2009.04.004
PMCID: PMC2709793  PMID: 19560631
fetal alcohol syndrome; fetal alcohol spectrum disorders; teratology; ethanol; prenatal
14.  Recruitment of Chinese American Elders into Dementia Research: The UCSF ADRC Experience 
The Gerontologist  2011;51(Suppl 1):S125-S133.
Purpose: To describe the results of efforts to recruit Asian Americans into longitudinal research on cognitive decline in aging. Design and Methods: Recruitment strategies include clinics for assessment of cognitive impairment at the University of California, San Francisco campus and San Francisco’s Chinatown, lectures to local health care providers and community members, participation in community events, and publications in mass media. Results: Over 200 Chinese patients were evaluated in our outreach clinic. Many were primarily Chinese speaking with low levels of education. One hundred and twenty-five participants enrolled, and annual follow-up has been 88%. Among enrollees, 36% were recruited from our clinical service; 30% via word of mouth; and the rest from community lectures and events, flyers, and mass media. Participants who enrolled were relatively highly educated, tended to be interested in learning about their cognitive abilities, and were supportive of the goals of research. Implications: Despite the significant cultural and linguistic barriers, Chinese Americans can be successfully recruited into longitudinal studies of aging and cognitive impairment. Clinical services are a critical component of such an effort, and low education and other factors that may be associated with it are clear barriers to research participation.
doi:10.1093/geront/gnr033
PMCID: PMC3092979  PMID: 21565814
Alzheimer’s disease; Asian and Pacific Rim Older Adults; Attitudes and perceptions toward aging/aged; Cognition; Cross-cultural studies; Dementia; Ethics (research, practice, policy, individual choices)
15.  Unraveling the genetic underpinnings of myeloproliferative neoplasms and understanding their effect on disease course and response to therapy: Proceedings from the 6th International Post-ASH Symposium 
American journal of hematology  2012;87(5):562-568.
Immediately after the annual scientific meeting of the American Society of Hematology (ASH), a select group of clinical and laboratory investigators in myeloproliferative neoplasms (MPN) is summoned to a post-ASH conference on chronic myeloid leukemia and the BCR-ABL1-negative MPN. The 6th such meeting occurred on 13th–14th December 2011, in La Jolla, California, USA, under the direction of its founder, Dr. Tariq Mughal. The current document is the first of two reports on this post-ASH event and summarizes the most recent preclinical and clinical advances in polycythemia vera, essential thrombocythemia and primary myelofibrosis.
doi:10.1002/ajh.23169
PMCID: PMC3491640  PMID: 22460584
ASXL1; EZH2; JAK2; myelofibrosis; myeloproliferative neoplasms; TET2; thrombocythemia
16.  First Reported Case of Cryptococcus gattii in the Southeastern USA: Implications for Travel-Associated Acquisition of an Emerging Pathogen 
PLoS ONE  2009;4(6):e5851.
In 2007, the first confirmed case of Cryptococcus gattii was reported in the state of North Carolina, USA. An otherwise healthy HIV negative male patient presented with a large upper thigh cryptococcoma in February, which was surgically removed and the patient was started on long-term high-dose fluconazole treatment. In May of 2007, the patient presented to the Duke University hospital emergency room with seizures. Magnetic resonance imaging revealed two large CNS lesions found to be cryptococcomas based on brain biopsy. Prior chest CT imaging had revealed small lung nodules indicating that C. gattii spores or desiccated yeast were likely inhaled into the lungs and dissemination occurred to both the leg and CNS. The patient's travel history included a visit throughout the San Francisco, CA region in September through October of 2006, consistent with acquisition during this time period. Cultures from both the leg and brain biopsies were subjected to analysis. Based on phenotypic and molecular methods, both isolates were C. gattii, VGI molecular type, and distinct from the Vancouver Island outbreak isolates. Based on multilocus sequence typing of coding and noncoding regions and virulence in a heterologous host model, the leg and brain isolates are identical, but the two differed in mating fertility. Two clinical isolates, one from a transplant recipient in San Francisco and the other from Australia, were identical to the North Carolina clinical isolate at all markers tested. Closely related isolates that differ at only one or a few noncoding markers are present in the Australian environment. Taken together, these findings support a model in which C. gattii VGI was transferred from Australia to California, possibly though an association with its common host plant E. camaldulensis, and the patient was exposed in San Francisco and returned to present with disease in North Carolina.
doi:10.1371/journal.pone.0005851
PMCID: PMC2689935  PMID: 19516904
17.  Health and Oral Health Care Needs and Health Care-Seeking Behavior Among Homeless Injection Drug Users in San Francisco 
Few existing studies have examined health and oral health needs and treatment-seeking behavior among the homeless and injection drug users (IDUs). This paper describes the prevalence and correlates of health and oral health care needs and treatment-seeking behaviors in homeless IDUs recruited in San Francisco, California, from 2003 to 2005 (N = 340). We examined sociodemographic characteristics, drug use patterns, HIV status via oral fluid testing, physical health using the Short Form 12 Physical Component Score, self-reported needs for physical and oral health care, and the self-reported frequency of seeking medical and oral health care. The sample had a lower health status as compared to the general population and reported a frequent need for physical and oral health care. In bivariate analysis, being in methadone treatment was associated with care-seeking behavior. In addition, being enrolled in Medi-Cal, California’s state Medicaid program, was associated with greater odds of seeking physical and oral health care. Methamphetamine use was not associated with higher odds of needing oral health care as compared to people who reported using other illicit drugs. Homeless IDUs in San Francisco have a large burden of unmet health and oral health needs. Recent cuts in Medi-Cal’s adult dental coverage may result in a greater burden of oral health care which will need to be provided by emergency departments and neighborhood dental clinics.
doi:10.1007/s11524-010-9498-5
PMCID: PMC3005094  PMID: 20945108
IDU; Homeless; Health Care; Oral Health; Methamphetamine; Dental Care
18.  Anal Cancer Incidence and Survival: Comparing the Greater San-Francisco Bay Area to Other SEER Cancer Registries 
PLoS ONE  2013;8(3):e58919.
The incidence of squamous cell carcinoma of the anus, anal canal, and anorectum (SCCA) has increased over time. However, there are still no national guidelines on screening for SCCA among high-risk populations. Providers at University of California, San Francisco have been at the forefront of providing anal dysplasia screening. To determine whether such a screening program allows for earlier detection of abnormalities and consequently, improves patient survival, we conducted an ecological study using data from the Surveillance, Epidemiology, and End Results (SEER) program to compare the San Francisco-Oakland catchment area (SF-O) to other SEER sites where routine screening has not been as accessible. Cox regression models were utilized to assess the impact of residing in the SF-O region, versus other SEER sites, on cause-specific mortality hazard. Logistic regression was used to determine if site was associated with the probability of having an in situ versus invasive tumor among SCCA cases. All analyses were stratified on calendar time (1985–1995 and 1996–2008) to compare differences pre- and post- highly active anti-retroviral therapy. Among SCCA cases, being reported by the SF-O registry was associated with a four fold higher probability of having an in situ tumor (rather than an invasive tumor) [95% CI: 3.48–4.61], compared to sites outside of California, between 1996 and 2008. Cases reported from the SF-O region between 1996 and 2008 had a 39% lower mortality risk than those reported from registries outside California (95% CI: 0.51–0.72). However, there was no decrease in the rate of invasive SCCA over this period. This is the first ecological study to evaluate whether access to anal cancer screening programs may help improve patient survival by allowing for earlier detection of lesions. Our results imply that routine screening programs may help detect SCCA at an earlier stage and thus, potentially impact patient survival.
doi:10.1371/journal.pone.0058919
PMCID: PMC3590168  PMID: 23484057
19.  Clinicopathologic Characteristics and Survival Outcomes of Patients With Fibrolamellar Carcinoma: Data From the Fibrolamellar Carcinoma Consortium 
ABSTRACT
BACKGROUND:
Fibrolamellar carcinoma is a rare and poorly understood malignancy that affects the young in the absence of underlying liver disease. Despite reported small review series, the literature lacks large retrospective studies that may help in understanding this disease.
METHODS:
Medical record review was undertaken for all patients histopathologically diagnosed with fibrolamellar carcinoma, seen at Memorial Sloan-Kettering Cancer Center, the University of California San Francisco, and Johns Hopkins Hospital from 1986 to 2011. Demographic, clinical, pathologic, and treatment data were recorded. Overall survival was estimated by using Kaplan-Meier methods. The impact of different clinicopathologic variables on survival was assessed with Cox regression models.
RESULTS:
Ninety-five patients were identified. Median age was 22 years, 86% were Caucasian, and 50% presented with stage IV disease. There were more females than males (58% vs. 42%). Seventy-seven percent of the patients underwent surgical resection and/or liver transplantation; of these 31.5% received perioperative therapy. Patients with unresectable disease, including 8 patients treated in clinical trials, were treated with chemotherapy, occasionally given with interferon or biologic agents. Ten patients received sorafenib, and 7 received best supportive care. Median survival was 6.7 years. Factors significantly associated with poor survival were female sex, advanced stage, lymph node metastases, macrovascular invasion, and unresectable disease.
CONCLUSIONS:
The clinicopathologic characteristics and survival outcomes from this dataset are consistent with those reported in the literature. Surgical resection and disease extent were confirmed as important predictors of survival. The possibility of a negative association between female sex and prognosis could represent a clue as to future therapeutic strategies.
PMCID: PMC3597938  PMID: 23505572
20.  Untreated brain arteriovenous malformation 
Neurology  2014;83(7):590-597.
Objective:
To identify risk factors for intracranial hemorrhage in the natural history course of brain arteriovenous malformations (AVMs) using individual patient data meta-analysis of 4 existing cohorts.
Methods:
We harmonized data from Kaiser Permanente of Northern California (n = 856), University of California San Francisco (n = 787), Columbia University (n = 672), and the Scottish Intracranial Vascular Malformation Study (n = 210). We censored patients at first treatment, death, last visit, or 10-year follow-up, and performed stratified Cox regression analysis of time-to-hemorrhage after evaluating hemorrhagic presentation, sex, age at diagnosis, deep venous drainage, and AVM size as predictors. Multiple imputation was performed to assess impact of missing data.
Results:
A total of 141 hemorrhage events occurred during 6,074 patient-years of follow-up (annual rate of 2.3%, 95% confidence interval [CI] 2.0%–2.7%), higher for ruptured (4.8%, 3.9%–5.9%) than unruptured (1.3%, 1.0%–1.7%) AVMs at presentation. Hemorrhagic presentation (hazard ratio 3.86, 95% CI 2.42–6.14) and increasing age (1.34 per decade, 1.17–1.53) independently predicted hemorrhage and remained significant predictors in the imputed dataset. Female sex (1.49, 95% CI 0.96–2.30) and exclusively deep venous drainage (1.60, 0.95–2.68, p = 0.02 in imputed dataset) may be additional predictors. AVM size was not associated with intracerebral hemorrhage in multivariable models (p > 0.5).
Conclusion:
This large, individual patient data meta-analysis identified hemorrhagic presentation and increasing age as independent predictors of hemorrhage during follow-up. Additional AVM cohort data may further improve precision of estimates, identify new risk factors, and allow validation of prediction models.
doi:10.1212/WNL.0000000000000688
PMCID: PMC4141996  PMID: 25015366
21.  Sewer pipe, wire, epoxy, and finger tapping: The start of fMRI at the Medical College of Wisconsin 
Neuroimage  2011;62(2):620-631.
In 1991, the Biophysics Research Institute at the Medical College of Wisconsin was among the first groups to develop functional Magnetic Resonance Imaging (fMRI). Our story is unique on a few levels: We didn’t have knowledge of the ability to image human brain activation with MRI using blood oxygenation dependent (BOLD) contrast until early August of 1991 when we attended the Society for Magnetic Resonance in Medicine (SMRM) meeting in San Francisco, yet we produced our first BOLD-based maps of motor cortex activation about a month later. The effort started with two graduate students, Eric Wong and myself. Only a few days prior to that extremely important SMRM meeting, we had developed human echo planar imaging (EPI) capability in-house. Wong designed, built, and interfaced a head gradient coil made out of sewer pipe, wire, and epoxy to a standard GE 1.5 T MRI scanner. Also, a few months prior to building this human head gradient coil he developed the EPI pulse sequences and image reconstruction. All of these efforts were towards a different goal – for demonstration of Wong’s novel approach to perfusion imaging in the human brain. Following SMRM, where a plenary lecture by Tom Brady from MGH opened our eyes to human brain activation imaging using BOLD contrast, and where we learned that EPI was extremely helpful if not critical to its success, we worked quickly to achieve our first results on September 14, 1991. The story is also unique in that Jim Hyde had set up the Biophysics Research Institute to be optimal for just this type of rapidly advancing basic technology research. It was well equipped for hardware development, had open and dynamic collaborative relationships with other departments, hospitals on campus, and GE, and had a relatively flat hierarchy and relaxed, flexible, collegial atmosphere internally. Since these first brain activation results, MCW Biophysics has continued to be at the forefront of functional MRI innovation, having helped to pioneer real time fMRI, high-resolution fMRI, and functional connectivity mapping.
doi:10.1016/j.neuroimage.2011.10.044
PMCID: PMC3303998  PMID: 22044784
22.  Air toxics and asthma: impacts and end points. 
Environmental Health Perspectives  1995;103(Suppl 6):209-211.
The National Urban Air Toxics Research Center (NUATRC) hosted a medical/scientific workshop focused on possible asthma/air toxics relationships, with the results of the NUATRC's first research contract with the University of Cincinnati as the point of discussion. The workshop was held at the Texas Medical Center on 4 February 1994 and featured presentations by distinguished academic, government, and industry scientists. This one-day session explored the impact of various environmental factors, including air toxics, on asthma incidence and exacerbation; an emphasis was placed on future research directions to be pursued in the asthma/air toxics area. A key research presentation on the association of air toxics and asthma, based on the study sponsored by NUATRC, was given by Dr. George Leikauf of the University of Cincinnati Medical Center. Additional presentations were made by H. A. Boushey, Jr., Cardiovascular Research Institute/University of California at San Francisco, who spoke on of the Basic Mechanisms of Asthma; K. Sexton, U.S. Environmental Protection Agency, who spoke on hazardous air pollutants: science/policy interface; and D. V. Bates, Department of Health Care and Epidemiology at the University of British Columbia, who spoke on asthma epidemiology. H. Koren, U.S. Environmental Protection Agency, and M. Yeung, of the Respiratory Division/University of British Columbia, Vancouver General Hospital, discussed occupational health impacts on asthma. Doyle Pendleton, Texas Natural Resource Conservation Commission, reviewed air quality measurements in Texas. The information presented at the workshop suggested a possible association of asthma exacerbations with ozone and particulate matter (PM10); however, direct relationships between worsening asthma and air toxic ambient levels were not established. Possible respiratory health effects associated with air toxics will require considerably more investigation, especially in the area of human exposure assessment. Two major recommendations for future research resulted from this workshop and an accompanying NUATRC Scientific Advisory Panel meeting: a need for more complete individual personal exposure assessments so that accurate determinations of actual personal exposures to various pollutants can be made; and a need for field experiments utilizing biomarkers of exposure and effect to more accurately assess the extent and variability of the biological effects, if any, of individual air toxics.
PMCID: PMC1518917  PMID: 8549475
23.  Simplifying Consent for HIV Testing Is Associated with an Increase in HIV Testing and Case Detection in Highest Risk Groups, San Francisco January 2003–June 2007 
PLoS ONE  2008;3(7):e2591.
Background
Populations at highest risk for HIV infection face multiple barriers to HIV testing. To facilitate HIV testing procedures, the San Francisco General Hospital Medical Center eliminated required written patient consent for HIV testing in its medical settings in May 2006. To describe the change in HIV testing rates in different hospital settings and populations after the change in HIV testing policy in the SFDH medical center, we performed an observational study using interrupted time series analysis.
Methods
Data from all patients aged 18 years and older seen from January 2003 through June 2007 at the San Francisco Department of Public Health (SFDPH) medical care system were included in the analysis. The monthly HIV testing rate per 1000 hadpatient-visits was calculated for the overall population and stratified by hospital setting, age, sex, race/ethnicity, homelessness status, insurance status and primary language.
Results
By June 2007, the average monthly rate of HIV tests per 1000 patient-visits increased 4.38 (CI, 2.17–6.60, p<0.001) over the number predicted if the policy change had not occurred (representing a 44% increase). The monthly average number of new positive HIV tests increased from 8.9 (CI, 6.3–11.5) to 14.9 (CI, 10.6–19.2, p<0.001), representing a 67% increase. Although increases in HIV testing were seen in all populations, populations at highest risk for HIV infection, particularly men, the homeless, and the uninsured experienced the highest increases in monthly HIV testing rates after the policy change.
Conclusions
The elimination of the requirement for written consent in May 2006 was associated with a significant and sustained increase in HIV testing rates and HIV case detection in the SFDPH medical center. Populations facing the higher barriers to HIV testing had the highest increases in HIV testing rates and case detection in response to the policy change.
doi:10.1371/journal.pone.0002591
PMCID: PMC2435630  PMID: 18596933
24.  Fatal heroin-related overdose in San Francisco, 1997–2000: a case for targeted intervention 
Heroin-related overdose is the single largest cause of accidental death in San Francisco. We examined demographic, location, nontoxicological, and toxicological characteristics of opiate overdose deaths in San Francisco, California. Medical examiner’s case files for every opioid-positive death from July 1, 1997, to June 30, 2000, were reviewed and classified as overdose deaths or other. Demographic variables were compared to two street-based studies of heroin users and to census data. From 1997 to 2000, of all heroin-related overdoses in San Francisco 47% occurred in low-income residential hotels; 36% occurred in one small central area of the city. In 68% of deaths, the victim was reportedly alone. When others were present between last ingestion of heroin and death, appropriate responses were rare. In three cases, police arrested the person who called emergency services or others present on the scene. We recommend the development of overdose response training targeted at heroin users and those close to them, including the staff of residential hotels.
doi:10.1093/jurban/jtg029
PMCID: PMC3456286  PMID: 12791802
Epidemiology; Heroin overdose; Injection drug users; San Francisco
25.  Pancreaticoduodenectomy: Volume is not Associated with Outcome within an Academic Health Care System 
HPB Surgery  2008;2008:825940.
Hypothesis. Smaller and lower-volume hospitals can attain surgical outcomes similar to high-volume centers if they incorporate the expertise and health care pathways of high-volume centers. Setting. The academic tertiary care center, Moffit-Long Hospital (ML); the community-based Mount Zion Hospital (ZION); the San Francisco County General Hospital (SFGH); and the Veterans Affairs Medical Center of San Francisco (VAMC). Patients. 369 patients who underwent pancreaticoduodenectomy between October 1989 and June 2003 at the University of California, San Francisco (UCSF) affiliated hospitals. Interventions. Pancreaticoduodenectomy. Design. Retrospective chart review. To correct for the potentially confounding effect of small case volumes and event rates, data for SFGH, VAMC, and ZION was combined (Small Volume Hospital Group; SVHG) and compared against data for ML. Main Outcome Measures. Complication rates; three-year and five-year survival rates. Results. The average patient age and health, as determined by ASA score, were similar between ML and the SVHG. The postoperative complication rate did not differ significantly between ML and the SVGH (58.8% versus 63.1%). Patients that experienced a complication averaged 2.5 complications in both groups. The perioperative mortality rate was 4% for patients undergoing pancreaticoduodenectomy at either ML or the SVGH. Although the 3-year survival rate for patients with adenocarcinoma of the pancreas was nearly twice as high at ML (31.2% versus 18.3% at SVHG), there was no significant difference in the 5-year survival rates (19% at ML versus 18.3% at SVHG). Conclusions. Low-volume hospitals can achieve similar outcomes to high-volume tertiary care centers provided they import the expertise and care pathways necessary for improved results.
doi:10.1155/2008/825940
PMCID: PMC2246060  PMID: 18475317

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