Medical Specialty Societies Research Articles

Putting professionalism and delivery of value‐added healthcare at the heart of physician training and continuing professional development

Putting professionalism and delivery of value‐added healthcare at the heart of physician training and continuing professional development

Critical Remarks

The authors did not give any search criteria for the selective literature search (key words, databases). The listing is not based on recommendations from international medical specialty societies (1). Altitude headache is not “migraine-like” but diffuse and thudding. Categorically advising against travel to altitudes higher than 2000 meters in various conditions is not differentiated enough. The deciding factor is the current function, for example after myocardial infarction (size, localization, effects [ejection fraction], complications, single-/multivessel disease, stent/aorto-coronary venous bypass [ACVB] graft, early acute recanalization, residual stenosis). Without these data, assessment is not possible in the individual case scenario. Alpine medical questions also remain unanswered (experience of mountaineering, economy of movement). An ICD patient in stable condition is principally fit to travel to high altitude. What is more important is the underlying disease. The same holds true for venous thrombosis or pulmonary embolism: a patient who is stable and whose fluid balance is also stable is fit to travel to high altitudes. In relation to patients with cardiopulmonary disorders, the oxygen diffusion impairment in interstitial lung disease was not mentioned. Older patients and obese patients should be asked about snoring (screening for sleep apnea). One of the cited studies has methodological weaknesses (2). A coauthor reported that the planned pre-acclimatization could not be realized because of significantly scattered data resulting from a deviation from the study protocol, owing to external circumstances (weather). No consensus exists regarding the protocol for pre-acclimatization in isobaric hypoxia, although there is no doubt that this is possible. Administering 2×125 mg/d acetazolamide results in fewer adverse effects while the effectiveness remains the same (3). Tadalafil has been recommended, although the data are scarce and substantial side effects at high altitudes have been reported. We cannot but agree wholeheartedly with the authors in that nifedipine and dexamethasone are essentials in a mountain guide’s emergency kit. We would make this a requirement for every mountaineer at high altitude. Summarized, these critical remarks intended to point out some limitations of the article, and it should be used with care for the purposes of CME.

The AAN's role in the development of health insurer coverage policy.

Scientific, evidence-based clinical practice guidelines (CPGs) differ from coverage/policy statements. The latter incorporate values and priorities and translate evidence into human benefit. They assist provider and payer decisions, and abide by extant laws and regulations. Payers have set internal processes for balancing and integrating the intent of CPGs into their coverage/payment policies. Recently, however, their efforts to reach out to respected medical specialty societies for input are increasing. In response, the American Academy of Neurology (AAN) has taken the following steps: 1) it is reacting to, and providing input to, payer requests for policy reviews; 2) it is taking a proactive approach by developing AAN guideline companion documents that describe potential provider impacts and policy implications; and 3) it is commencing an initiative to write its own template policies. This new involvement has met with initial positive outcomes. The AAN will continue to expand efforts to fulfill a growing need in this area.

An analysis of AAN's evidence-based guideline for IVIg use in neurologic disorders: Provider impact and payer perspectives.

Health insurers look for reliable, published evidence such as evidence-based guidelines put forth by medical specialty societies to craft their coverage policies. These guidelines generate both beneficial and controversial consequences on policies. Coverage policies aim to address the most typical clinical presentations. The American Academy of Neurology guideline for IV immunoglobulin strengthens the case for coverage when it is used to treat Guillain-Barré syndrome and chronic inflammatory demyelinating polyradiculoneuropathy. The guideline is less likely to strengthen coverage for several other diagnoses with lower levels of evidence. The responsibility to clarify specific situations when patient need falls outside of what is considered to be routine evaluation or treatment rests heavily on the physician. Advice on appealing an unfavorable coverage decision is also provided to the reader.

Management of Group B Streptococcal Bacteriuria in Pregnancy

ObjectiveTo provide information regarding the management of group B streptococcal (GBS) bacteriuria to midwives, nurses, and physicians who are providing obstetrical care. OutcomesThe outcomes considered were neonatal GBS disease, preterm birth, pyelonephritis, chorioamnionitis, and recurrence of GBS colonization. EvidenceMedline, PubMed, and the Cochrane database were searched for articles published in English to December 2010 on the topic of GBS bacteriuria in pregnancy. Bacteriuria is defined in this clinical practice guideline as the presence of bacteria in urine, regardless of the number of colony-forming units per mL (CFU/mL). Low colony counts refer to < 100 000 CFU/mL, and high (significant) colony counts refer to ≥ 100 000 CFU/mL. Results were restricted to systematic reviews, randomized controlled trials, and relevant observational studies. Searches were updated on a regular basis and incorporated in the guideline to February 2011. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. ValuesRecommendations were quantified using the evaluation of evidence guidelines developed by the Canadian Task Force on Preventive Health Care (Table). Benefits, Harms, and CostsThe recommendations in this guideline are designed to help clinicians identify pregnancies in which it is appropriate to treat GBS bacteriuria to optimize maternal and perinatal outcomes, to reduce the occurrences of antibiotic anaphylaxis, and to prevent increases in antibiotic resistance to GBS and non-GBS pathogens. No cost-benefit analysis is provided.

Choosing Wisely

WHILE THE UNITED STATES GRAPPLES WITH THE challenge of health care costs that contribute to high rates of poor-quality care, burdens to business competitiveness, and looming government deficits, clearly there are areas in which health care spending does not add to the health of individuals and communities. The polarizing political environment makes it difficult to conduct rational public discussions about this issue, but clinicians and consumers can change the nature of this debate to the potential benefit of patients, the medical profession, and the nation. The initial focus should be on overuse of medical resources, which not only is a leading factor in the high level of spending on health care but also places patients at risk of harm. In fact, some estimates suggest that as much as 30% of all health care spending is wasted. To reduce unnecessary tests and procedures, physicians will need to play a leading role—their decisions account for about 80% of health care expenditures. Yet physicians do not always have the most current effectiveness data, and despite acting in good faith, they can recommend diagnostic or therapeutic interventions that are no longer considered essential. Also, research shows that physicians may need help communicating these matters to their patients. This may be especially difficult when clinicians and consumers are deluged with advertising and promotion. Clinicians often report feeling compelled to accommodate patients’ requests for interventions they know are unnecessary. At the same time, patients need trustworthy information to help them better understand that more care is not always better care, and in some cases can actually cause more harm than good. A major goal of health care reform is enhancing “patientcentered care.” Patients, and consumer groups representing them, express increasing interest in forging true partnerships with their clinicians, with real-time access to their own medical records, to science-based comparative effectiveness information, and to health care delivery environments built to enhance both comfort and personalization of medical care. Patient engagement, as 1 of the 6 major initiatives of the National Priorities Partnership of the National Quality Forum, promises more informed and involved patients as decision makers. To make good on this promise requires transparent and credible information about the relative value and risk of various medical diagnostic and therapeutic interventions. To help reduce waste in the US health care system and promote physician and patient conversations about making wise choices about treatments, 9 medical specialty societies have joined the ABIM (American Board of Internal Medicine) Foundation and Consumer Reports in the first phase of the Choosing Wisely campaign, including the following: American Academy of Allergy, Asthma & Immunology; American Academy of Family Physicians; American College of Cardiology; American College of Physicians; American College of Radiology; American Gastroenterological Association; American Society of Clinical Oncology; American Society of Nephrology; and the American Society of Nuclear Cardiology. As part of Choosing Wisely, each society has developed a list of 5 tests, treatments, or services that are commonly used in that specialty and for which the use should be reevaluated by patients and clinicians. Those lists were released on April 4, 2012, at a national event in Washington, DC. Additionally, other societies, consumer organizations, and physician organizations have asked how they can become part of this effort to engage physicians and patients in conversations about tests and procedures that should rarely be used. The early origins of this campaign can be found in “Medical Professionalism in the New Millennium: A Physician Charter.” Authored in 2002 by the ABIM Foundation, American College of Physicians Foundation, and European Federation of Internal Medicine, the charter has as its fundamental principles the primacy of patient welfare, pa-

Antibiotic Prophylaxis in Gynaecologic Procedures

ObjectiveTo review the evidence and provide recommendations on antibiotic prophylaxis for gynaecologic procedures. OutcomesOutcomes evaluated include need and effectiveness of antibiotics to prevent infections in gynaecologic procedures. EvidenceMedline and The Cochrane Library were searched for articles published between January 1978 and January 2011 on the topic of antibiotic prophylaxis in gynaecologic procedures. Results were restricted to systematic reviews, randomized control trials/ controlled clinical trials, and observational studies. Searches were updated on a regular basis and incorporated in the guideline to June 2011. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. ValuesThe quality of evidence obtained was rated using the criteria described in the Report of the Canadian Task Force on Preventative Health Care (Table 1). Benefits, harms, and costsGuideline implementation should result in a reduction of cost and related harm of administering antibiotics when not required and a reduction of infection and related morbidities when antibiotics have demonstrated a proven benefit. Recommendations1.All women undergoing an abdominal or vaginal hysterectomy should receive antibiotic prophylaxis. (I-A)2.All women undergoing laparoscopic hysterectomy or laparoscopically assisted vaginal hysterectomy should receive prophylactic antibiotics. (III-B)3.The choice of antibiotic for hysterectomy should be a single dose of a first-generation cephalosporin. If patients are allergic to cephalosporin, then clindamycin, erythromycin, or metronidazole should be used. (I-A)4.Prophylactic antibiotics should be administered 15 to 60 minutes prior to skin incision. No additional doses are recommended. (I-A)5.If an open abdominal procedure is lengthy (e.g., > 3 hours), or if the estimated blood loss is > 1500 mL, an additional dose of the prophylactic antibiotic may be given 3 to 4 hours after the initial dose. (III-C)6.Antibiotic prophylaxis is not recommended for laparoscopic procedures that involve no direct access from the abdominal cavity to the uterine cavity or vagina. (l-E)7.All women undergoing surgery for pelvic organ prolapse and/or stress urinary incontinence should receive a single dose of firstgeneration cephalosporin. (III-B)8.Antibiotic prophylaxis is not recommended for hysteroscopic surgery. (II-2D)9.All women undergoing an induced (therapeutic) surgical abortion should receive prophylactic antibiotics to reduce the risk of postabortal infection. (I-A)10.Prophylactic antibiotics are not suggested to reduce infectious morbidity following surgery for a missed or incomplete abortion. (I-E)11.Antibiotic prophylaxis is not recommended for insertion of an intrauterine device. (I-E) However, health care professionals could consider screening for sexually transmitted infections in high-risk populations. (III-C)12.There is insufficient evidence to support the use of antibiotic prophylaxis for an endometrial biopsy. (III-L)13.The best method to prevent infection after hysterosalpingography is unknown. Women with dilated tubes found at the time of hysterosalpingography are at highest risk, and prophylactic antibiotics (e.g., doxycycline) should be given. (II-3B)14.Antibiotic prophylaxis is not recommended for urodynamic studies in women at low risk, unless the incidence of urinary tract infection post-urodynamics is > 10%. (1-E)15.In patients with morbid obesity (BMI > 35 kg/m2), doubling the antibiotic dose may be considered. (III-B)16Administration of antibiotics solely to prevent endocarditis is not recommended for patients who undergo a genitourinary procedure. (III-E)

American Academy of Neurology policy on pharmaceutical and device industry support

To examine the American Academy of Neurology (AAN)'s prevention and limitation of conflicts of interest (COI) related to relationships with pharmaceutical and medical device manufacturers and other medically related commercial product and service companies (industry). We reviewed the AAN's polices governing its interactions with industry, mechanisms for enforcement, and the recent findings of the board-appointed COI task force, in the context of the 2009 David Rothman and colleagues' article in JAMA, the Council of Medical Specialty Societies (CMSS) Code for Interactions with Companies (Code), efforts of the American Medical Association in this area, and increased public and Congressional scrutiny of physician/physician organizations' relationships with industry. The AAN's Policy on Conflicts of Interest provides 4 mechanisms for addressing COI: avoidance, separation, disclosure, and regulation. The AAN's Principles Governing Academy Relationships with External Sources of Support, including recent amendments proposed by the COI task force, regulate industry interaction with AAN programming, products, and leadership. With the Policy, Principles, and other methods of COI prevention, the AAN meets or exceeds all recommendations of the CMSS Code. With its adherence to the Principles since 2004, the AAN has been a leader among professional medical associations in appropriately managing COI related to interactions with industry. Recent amendments to the Principles maintain the AAN's position as a leader in a time of increased public scrutiny of physicians' and professional medical associations' relationships with industry. The AAN is responsive to the recommendations of the COI task force, and has adopted the CMSS Code.

RETIRED: Genetic Considerations for a Woman’s Annual Gynaecological Examination

To provide the physician with an overview of common genetic conditions that should be considered during a women's annual gynaecological assessment to determine the patient's risk or to initiate specific testing or referral to another subspecialty service, depending on personal or family history. This genetic information can be used for patient education and possible disease and/or mutation screening or diagnosis. The use of this genetic information may allow improved risk-benefit assessment and management at the annual gynaecological examination. Studies published in English up to and including May 2010 were retrieved through searches of PubMed and the Cochrane Library, using appropriate controlled vocabulary (gynaecological diagnosis, genetic inheritance) and key words (genetic risk, genetic mutation, inheritance, family history, uterus, ovary, endometrial, vagina, colon, gastric, renal, breast, cardiac, thrombophilia, diabetes, epilepsy, leiomyomata uteri). Other literature sources were identified through searching the web sites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The levels of evidence are not adequate for evidence-based recommendations to be made. This committee opinion will enhance the use of new genetic knowledge and its application to the annual gynaecological care of women. Risk management and diagnostic opportunities for genetic gynaecological conditions will be improved. A more complete understanding of genetic conditions may increase anxiety and psychological stress for women and their families. Society of Obstetricians and Gynaecologists of Canada. The levels of evidence are not adequate for evidence-based recommendations to be made.

The Million Hearts Initiative—Targeting Key Drivers of Cardiovascular Mortality from a Medical Specialty Society Perspective

The past decade has seen impressive advances in cardiovascular (CV) care and reductions in patient mortality from CV disease. however, despite impressive gains, there is still considerable room for further improvements in CV care. in September 2011, the US Secretary of Health and Human Services Kathleen Sebelius announced the creation of the ‘Million Hearts’ initiative. The overall goal of the Million Hearts Initiative is to prevent a million cardiovascular events across the next five years. The American College of Cardiology (ACC) has long supported the goals articulated in Million Hearts. We believe that these goals are achievable. However, success will not be automatic. It will require focus, resources, and, most challengingly, some level of behavioral change on the part of physicians, patients, organizations, and government entities. To help meet the goals of Million Hearts, the ACC will, in partnership with the initiative, deploy three distinct assets. We will increase awareness among our 39,000 members by regularly communicating with them via our various communication channels; we will drive clinical quality improvement using our clinical registries—for example, the PINNACLE Registry®; and we will engage patients with relevant, patient-centered offerings and information through our CardioSmartTM program.

The Harms of Screening

AMERICANS ARE ENTHUSIASTIC ABOUT SCREENING, ESpecially cancer screening. What could be wrong with screening, especially if it can detect a lifethreatening condition at an earlier stage? Trials show that early detection of breast, colorectal, and other cancers can reduce cause-specific mortality rates, and the same could apply to other conditions. With presumably little to lose and much to gain from early detection, why recommend against screening unless the concern is costs? Are lives being lost to save money? But costs are rarely the reason that guidelines set limits on screening. Most screening controversies turn on how to balance potential harms relative to potential benefits. Harms from screening programs are real; the burden of these harms can be disputed, but their existence cannot. Screening can produce iatrogenic complications (eg, perforation from colonoscopy), anxiety over abnormal results, and a cascade of follow-up tests and treatments. Screening can also precipitate overdiagnosis, the workup and treatment of conditions that qualify as disease but pose little threat to patients’ health. Concerns about the harms of screening might seem exaggerated without closer scrutiny. For instance, if a test with 90% sensitivity and 96% specificity (better than most screening tests) is used to screen for a condition with a prevalence of 0.6% (typical of some cancers), 88% of abnormal results will be erroneous; for every 1000 patients screened, only 6 will have the condition and 40 will have falsepositive results. That ratio may be acceptable if the benefits obtained by the 6 patients with true disease outweigh the harms incurred by the 1000 patients who undergo screening, but what if there is little evidence that early detection improves their prognosis? If only 1 or 2 of the 6 patients obtain benefit, is it ethical to subject the entire population to screening? The concern about overdiagnosis is justified: by some estimates, overdiagnosis accounts for 15% to 25% of screen-detected lung cancers and potentially more breast and prostate cancers. Whether the harms are important enough to limit screening has been a vociferous debate for decades. In the 1980s, the most cautious groups—notably the US Preventive Services Task Force (USPSTF)—broke sharply with proponents of screening. Skeptics argued that the potential harms made it unethical to recommend screening without compelling scientific evidence of meaningful benefits (eg, lower morbidity/mortality). The proponents (eg, American Cancer Society, American College of Radiology) dismissed concerns about harms and warned that waiting for definitive evidence would cost lives. In the 1990s, the opposing parties found middle ground as both the science and respect for harms became stronger. In 1992, citing mounting evidence of benefits, the USPSTF abandoned its earlier skepticism and endorsed fecal and sigmoidoscopy screening for colorectal cancer. In 2000 and 2001, respectively, the American Urological Association and American Cancer Society recommended that men obtain information about harms before undergoing prostatespecific antigen (PSA) screening. In 2002, the USPSTF added colonoscopy as a screening option and abandoned its opposition to mammography screening for women 40 years and older. However, a largely unnoticed caveat in the 2002 mammography guideline revealed continuing concern about harms: “The precise age at which the benefits from screening mammography justify the potential harms is a subjective judgment and should take into account patient preferences. Clinicians should inform women about the potential benefits . . . , potential harms . . . , and limitations . . . that apply to women their age.” In 2008, the apparent consensus in guidelines began to unravel. Two colorectal cancer screening tests that the USPSTF found lacking in evidence—fecal DNA testing and computerized tomographic colonography—were endorsed by the American Cancer Society and medical specialty societies. In 2009, the USPSTF issued a controversial recommendation against “routine” mammography among women aged 40 to 49 years. Amplifying its earlier caveat, the USPSTF urged women of this age group to first make an informed decision with their physician that considered individual clinical context and “the patient’s values regarding specific benefits and harms.” In 2011, concern about

Will Performance Measurement Lead to Better Patient Outcomes?: What Are the Roles of the National Quality Forum and Medical Specialty Societies?

Performance measures (PMs) are specified metrics by which a health-care provider's care can be compared with national benchmarks. The use of PMs is a key component of efforts to improve the quality and value of health care. The National Quality Forum (NQF) is the federally recognized endorser of PMs. From 2006 to 2009, the Quality Improvement Committee (QIC) of the American College of Chest Physicians engaged in the review of proposed PMs as a member of the NQF. This article provides a review of the QIC's experience with PMs and NQF membership and the lessons learned, an overview of the enhancements made to the NQF endorsement process in 2010 and 2011, and a discussion of the next steps that would further strengthen the measure development and endorsement processes and increase the likelihood of measurement leading to better patient outcomes.

Adoption of electronic health records by medical specialty societies

Rao et al ,1 by identifying barriers to adoption of electronic health records (EHRs) by physicians in small practices, help target interventions. One intervention that merits consideration is the adoption of EHRs by medical specialty societies.2 A medical specialty society could select an existing web-based EHR and host it on the society's servers for the society's members who have not yet adopted an EHR. Physicians in small practices are concerned about financial barriers.1 Collectively, through their professional association, they would benefit from economies of scale. The American Psychiatric Association has, for example, 36 000 members,3 of which 30%, or 10 000, may be in small practices. Physicians in small practices are concerned about future obsolescence.1 With the market share delivered by the medical specialty society, the vendor would be able to stay in business and to continue to improve its EHR. Furthermore, the society, as …

Screening, Diagnosis, and Management of Intrauterine Growth Restriction

ObjectiveTo provide comprehensive background knowledge relevant to the SOGC Maternal-Fetal Medicine Committee-approved guideline entitled “Intrauterine Growth Restriction: Screening, Diagnosis, and Management.” MethodsPublications in English were retrieved through searches of PubMed or Medline, CINAHL, and the Cochrane Library in January 2011 using appropriate controlled vocabulary via MeSH terms (fetal growth restriction and small for gestational age) and any key words (fetal growth, restriction, growth retardation, intrauterine growth restriction [IUGR], low birth weight, small for gestational age). Results were restricted to systematic reviews, randomized controlled trials or controlled clinical trials, and highquality prospective and retrospective observational studies. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. ResultsEvidence obtained from at least one properly randomized controlled trial, Cochrane Reviews, and high quality cohort data have been combined to provide clinicians with evidence to optimize their practice for screening, diagnosis, and management of intrauterine growth restriction. ConclusionConsiderable advances have been made to improve clinicians’ ability to screen, diagnose, and manage pregnancies with suspected IUGR more effectively, including several properly randomized controlled trials. Pregnancies with late-onset IUGR may be managed equally effectively by early delivery or delayed delivery (with increased surveillance) anticipating favourable outcomes. By contrast, many aspects of the management of earlyonset IUGR require further clinical trials.

Delayed Child-Bearing

ObjectiveTo provide an overview of delayed child-bearing and to describe the implications for women and health care providers. OptionsDelayed child-bearing, which has increased greatly in recent decades, is associated with an increased risk of infertility, pregnancy complications, and adverse pregnancy outcome. This guideline provides information that will optimize the counselling and care of Canadian women with respect to their reproductive choices. OutcomesMaternal age is the most important determinant of fertility, and obstetric and perinatal risks increase with maternal age. Many women are unaware of the success rates or limitations of assisted reproductive technology and of the increased medical risks of delayed child-bearing, including multiple births, preterm delivery, stillbirth, and Caesarean section. This guideline provides a framework to address these issues. EvidenceStudies published between 2000 and August 2010 were retrieved through searches of PubMed and the Cochrane Library using appropriate key words (delayed child-bearing, deferred pregnancy, maternal age, assisted reproductive technology, infertility, and multiple births) and MeSH terms (maternal age, reproductive behaviour, fertility). The Internet was also searched using similar key words, and national and international medical specialty societies were searched for clinical practice guidelines and position statements. Data were extracted based on the aims, sample, authors, year, and results. ValuesThe quality of evidence was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). SponsorThe Society of Obstetricians and Gynaecologists of Canada. Recommendations1.Women who delay child-bearing are at increased risk of infertility. Prospective parents, especially women, should know that their fecundity and fertility begin to decline significantly after 32 years of age. Prospective parents should know that assisted reproductive technologies cannot guarantee a live birth or completely compensate for age-related decline in fertility. (II-2A)2.A fertility evaluation should be initiated after 6 months of unprotected intercourse without conception in women 35 to 37 years of age, and earlier in women > 37 years of age. (II-2A)3.Prospective parents should be informed that semen quality and male fertility deteriorate with advancing age and that the risk of genetic disorders in offspring increases. (II-2A)4.Women ≥ 35 years of age should be offered screening for fetal aneuploidy and undergo a detailed second trimester ultrasound examination to look for significant fetal birth defects (particularly cardiac defects). (II-1A)5.Delayed child-bearing is associated with increased obstetrical and perinatal complications. Care providers need to be aware of these complications and adjust obstetrical management protocols to ensure optimal maternal and perinatal outcomes. (II-2A)6.All adults of reproductive age should be aware of the obstetrical and perinatal risks of advanced maternal age so they can make informed decisions about the timing of child-bearing. (II-2A)7.Strategies to improve informed decision-making by prospective parents should be designed, implemented, and evaluated. These strategies should provide opportunity for adults to understand the potential medical, social, and economic consequences of child-bearing throughout the reproductive years. (III-B)8.Barriers to healthy reproduction, including workplace policies, should be reviewed to optimize the likelihood of healthy pregnancies. (III-C)

Compliance

Compliance

Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals

In recent years, Mayo Clinic Proceedings has published a variety of articles dealing with important, broad-reaching matters of societal interest that impact medicine and patient care. Topics included ideal physician behaviors, gender and medical career mentoring, advance directives and end-of-life issues, physician involvement in capital punishment, and, germane to this article, institutional conflicts of interest (COIs), as well as the journal's approach to publication of industry-sponsored clinical research.1-15 Equally important to the well-being of patients and of medicine is the legitimacy of interactions between industry sponsors of research and investigator-authors who communicate the information and the journals/editors who review and ultimately determine publication of the material. In this age of transparency, disclosure of COIs has assumed great prominence in medical journals. However, transparency is not always clear, disclosure policies are varied, and their implementation (by journals and medical societies) is asymmetric and biased. This commentary examines some prominent recent actions by consultants to plaintiffs' attorneys and a series of publications in 3 top-tier general medical journals that illustrate selective and incomplete disclosure of conflicts—both financial and otherwise. In my view, these events call into question actions by a medical specialty society with one of the consultants and, more broadly, the editorial practices at the journals concerning COIs. Specific recommendations are offered to address the latter. In April 2008, the Journal of the American Medical Association (JAMA) published a “research” article by Ross, Hill, Egilman, and Krumholz16 that was based on materials obtained through legal discovery; the authors claimed that Merck & Co, Inc (Whitehouse Station, NJ) previously hired professional writers (termed ghostwriters) to draft papers concerning clinical trials of rofecoxib (Vioxx) and invited academic physicians to accept authorship of them (without acknowledgment of the compensated writing) to increase their credibility. These guest authors supposedly made little contribution to the research, analysis, or interpretation of the data, an unacceptable practice. Many of the articles were from the mid- to late 1990s. JAMA issued press releases and an accompanying editorial17 that berated medical product companies broadly for manipulating clinical research, with resulting widespread media coverage. Some other journals opposed JAMA's posture.18 Several direct responses to JAMA by authors of publications listed in the article pointed out lapses in the report by Ross et al and mistaken inclusion of their publications in the analysis, with predictable rejoinders by the authors and editors.19-25 One letter23 suggested that “an author's declaration of financial dealings with industry is only meaningful if the monetary value received from each company over a preceding period (perhaps the past 2 years) is clearly stated,” a point to which I will return. I have worked in both academia and industry, including more than 17 years through 2006 at Merck, primarily in clinical drug development. From 2001 to 2006, this included management of a department of medical writers, support staff, and statisticians who worked with Merck scientists and external investigators to publish many (although not all) articles related to mid- and late-phase clinical trials sponsored by Merck. We adhered to the authorship criteria of the ICMJE (International Committee of Medical Journal Editors) and acknowledged lesser contributions to manuscripts by persons who did not meet those criteria. (The ICMJE states that, “Authorship credit should be based on (1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; (2) drafting the article or revising it critically for important intellectual content; and (3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.”)26 These criteria are widely used in biomedical research, although by no means universally. Speaking only for myself, and in no way as a spokesperson, this is not a defense of Merck or of actions related to Vioxx. However, readers may have a different perspective concerning the report of supposed authorship misconduct by Merck when they learn what was not disclosed by Ross et al or by JAMA. That article16 (and the others discussed subsequently) illustrates the far-reaching influence of the American tort bar,27 now impacting the content of important medical journals to further its litigation interests, abetted by journal editors who appear biased against industry. For editorial comment, see page 771

Conflicts—and Consensus—about Conflicts of Interest in Medicine

Conflicts—and Consensus—about Conflicts of Interest in Medicine Matthew K. Wynia and Bette–Jane Crigger* This fascinating collection of essays about individual experiences of conflict of interest leaves little doubt that physicians remain divided about the importance, impact and meaning of conflicts of interest in their work. These essays offer differing views about what conflicts of interest look and feel like “on the ground” and about whether specific conflicts of interest are bad, just a fact of life, or maybe even good. Conflict, Conflict Everywhere These essays situate conflict of interest in a variety of contexts: the treatment recommendations a physician makes for an individual patient; the relationship between teaching physician and medical student or practicing physician and health care organization; the interaction between academic researchers and industry collaborators or professional bodies and industry supporters. In this, the narratives taken together reflect the scope of concern about conflict of interest in medicine familiar in the literature. In his classic 1993 essay, Dennis Thompson noted that concerns about conflict of interest encompass issues of physician self–referral, risk sharing between physicians and health care institutions, gifts from industry, hospital purchasing practices, as well as sponsored research and research with patients (Thompson 1993). To that list have subsequently been added relationships with industry in medical education at all levels, physicians’ service as consultants to industry or members of industry speakers bureau, and development of clinical practice guidelines (Lo & Fields 2009). That almost none of these essays draw attention to some widely publicized situations of conflict of interest—for example, gifts to physicians or the provision of drug samples—should, we think, be seen more as an artifact of the authors’ varied individual experiences than as a failure by the authors to engage key concerns in the ongoing professional and public debate. It could also be that the authors, asked to submit personal stories, assumed that yet another essay about the ‘traditional’ issues in the conflicts of interest literature would be seen as redundant, routine or even boring. Or, there is the tantalizing possibility that the absence of some of the more familiar conflicts from these narratives is the early fruit of efforts to address these traditional issues through policies governing interactions between physicians and industry promulgated by academic medical centers and health systems, medical specialty societies, and industry. One significant area of concern that has emerged in recent years is conflict of interest in the development of clinical practice guidelines. E.g., Choudry et al. 2002; Sniderrman & Furberg 2009; Guyatt et al. 2010. Although none of the essays in this [End Page 101] collection address it head on, Perlmutter touches on several key issues. His depiction of how an FDA committee process limited the input he was able to provide as an expert, undermined his potential to contribute to the professional dialogue, and raised concerns about the objectivity of the drug approval process echoes concerns about objectivity, the role of expert opinion, and the presence on guideline development panels of individuals with financial interests in the recommendations to be developed that have been explored at some length in the literature, most recently by the Institute of Medicine in reports on evidentiary standards (Eden et al 2011) and principles for guideline development (Graham et al. 2011). Conflict of Interest or Dual Agency? Several essays set out physicians’ experience in navigating situations of diverging expectations. Bierut, for example, reflects on the disjunction between the goals and products of academic researchers and commercial sponsors. She saw herself advancing basic knowledge and was forced to grapple with the reality of sponsors’ goals to advance commercial ends as well. Nagldinne and Mikulec each recall struggles to reconcile their obligation to exercise professional judgment on behalf of patients with the demands of health care organizations focussed also on the bottom line. Cruz–Flores attests to the challenge of making recommendations for care when one is both a practicing clinician and a clinical investigator engaged in research that might offer benefit to a patient for whom there are limited options. Thompson defined conflicts of interest as “a set of conditions in which professional judgment concerning a primary interest (such as a patient’s welfare or the validity of...

Use of a DNA Method, QF-PCR, in the Prenatal Diagnosis of Fetal Aneuploidies

ObjectiveTo provide Canadian health care providers with current information on the use of quantitative fluorescent polymerase chain reaction (QF-PCR) or equivalent technology in the prenatal diagnosis of fetal chromosomal abnormalities. OptionsOver the last few decades, prenatal diagnosis of fetal chromosomal abnormalities has relied on conventional cytogenetic analysis of cultured amniocytes, chorionic villi, or fetal blood. In the last few years, the clinical validity of a newer technique, QF-PCR, to detect the common aneuploidies has been reported by a number of investigators. This technique has the advantage of providing rapid results for the diagnosis or exclusion of aneuploidy in chromosomes 13, 18, 21, X or Y. It is now possible to choose standard chromosome analysis or QF-PCR for the prenatal diagnosis of chromosomal abnormalities, or to perform both tests, depending on the clinical indication for testing. This document reviews the clinical utility of QF-PCR and makes recommendations for its use in the care of Canadian patients. EvidenceMedline and PubMed were searched for articles published in English between January 2000 and December 2010 that presented data on the use of QF-PCR versus standard cytogenetic analysis of prenatal samples. A second search was done to identify publications in English that provided results of cytogenetic analysis performed on prenatal samples for women at an increased risk of fetal aneuploidy because of maternal age, abnormal prenatal screening results, or fetal soft ultrasound markers suggestive of an increased risk of aneuploidy. Publications were included if they provided detailed information on the abnormalities detected, regardless of whether or not rapid aneuploidy screening was undertaken.Results were restricted to systematic reviews, randomized controlled trials, and relevant observational studies. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. ValuesThe quality of evidence was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). Benefits, harms, and costsThis guideline promotes the use of a rapid aneuploidy DNA test for women at increased risk of having a pregnancy affected by a common aneuploidy. This will have the benefit of providing rapid and accurate results to women at increased risk of fetal Down syndrome, trisomy 13, trisomy 18, sex chromosome aneuploidy or triploidy. It will also promote better use of laboratory resources and reduce the cost of prenatal diagnosis. However, a small percentage of pregnancies with a potentially clinically significant chromosomal abnormality will remain undetected by QF-PCR but detectable by conventional cytogenetics. Recommendations1. QF-PCR is a reliable method to detect trisomies and should replace conventional cytogenetic analysis whenever prenatal testing is performed solely because of an increased risk of aneuploidy in chromosomes 13, 18, 21, X or Y. As with all tests, pretest counselling should include a discussion of the benefits and limitations of the test. In the initial period of use, education for health care providers will be required. (II-2A)2. Both conventional cytogenetics and QF-PCR should be performed in all cases of prenatal diagnosis referred for a fetal ultrasound abnormality (including an increased nuchal translucency measurement > 3.5 mm) or a familial chromosomal rearrangement. (II-2A)3. Cytogenetic follow-up of QF-PCR findings of trisomy 13 and 21 is recommended to rule out inherited Robertsonian translocations. However, the decision to set up a back-up culture for all cases that would allow for traditional cytogenetic testing if indicated by additional clinical or laboratory information should be made by each centre offering the testing according to the local clinical and laboratory experience and resources. (III-A)4. Other technologies for the rapid detection of aneuploidy may replace QF-PCR if they offer a similar or improved performance for the detection of trisomy 13, 18, 21, and sex chromosome aneuploidy. (III-A)

Conflict of interest and the Society for Vascular Surgery

Specialty medical societies such as Society for Vascular Surgery (SVS) are instrumental in the development and dissemination of medical knowledge through scientific presentations, publication of rigorously peer-reviewed writings, awarding competitive research and training grants, and the provision of high-quality continuing medical education (CME). It is vital that in these roles the SVS remain in fact and in perception completely free of all influence and bias from industry. While independence from bias has always been necessary, the increasing focus by governmental agencies, industry organizations, and society has made it important for the SVS to address this issue in a formal way. In June 2010, the SVS Board of Directors approved a set of guidelines specifically designed to address management of conflict of interest among its members and its leaders. These guidelines, included in this article, were based on currently available information and policies put forth by legislative bodies, academic medical centers, industry groups, and other professional medical societies, and were designed to safeguard against abuse while maintaining valuable collaboration between vascular surgeons and their industry partners. The guidelines are included in this article.