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PubMed2003

Facial appearance and judgments of credibility: the effects of facial babyishness and age on statement credibility.

Researchers have found that facial appearance influences social judgments. For example, evidence has shown that facial babyishness and age affect perceivers' impressions of the stimulus person's veracity. In this experiment, the researchers examined whether these variables also influenced the credibility attributed to written statements purportedly made by these people in addition to several topics of interest in deception-detection research. Undergraduates (N = 270) were presented babyfaced or mature-faced photographs that depicted a child, an adult, or an older individual, in addition to a written truthful or deceptive statement purportedly made by the person in the photograph. Results showed that, as predicted, when the statements were accompanied by babyfaced pictures, participants tended to judge them as truthful, but only if the pictures did not depict children. Also, when the statements were accompanied by childen's pictures, participants tended to judge them as deceptive, but only if the pictures depicted a babyish face. Overall detection accuracy was close to chance and did not correlate with either judgmental confidence or with the respondents' estimated lie-detection accuracy. However, confidence and estimated ability were significantly correlated. Also, more confidence was placed in judgments of truthfulness than in judgments of deceptiveness. Respondents' truth bias and the existence of a veracity effect in the diverse experimental conditions were examined as well.

Adolescent↗

PubMed2004

Writing a police statement.

BACKGROUND: Requests for police statements regarding a patient's medical condition or injuries are common. A lack of training in their preparation, coupled with ignorance as to their fate, combine to make the task one which is generally viewed as a necessary paperwork evil. OBJECTIVE: This article aims to provide practical guidelines and a suggested format for use when preparing a police statement. DISCUSSION: Police statements prepared by medical practitioners are important documents whose intended audience is overwhelmingly nonmedical. A small time investment made in the preparation of a concise, objective report in language likely to be understood by the lay person will assist the courts in understanding complex medical issues and may obviate the need for the doctor to appear in court as a witness. A structured statement 'proforma' can be readily customised and will both reduce time in preparation of reports and serve as a prompt for inclusion of essential details.

Australia↗

PubMed1996

Protocol for writing cause-of-death statements for deaths due to natural causes.

The purpose of this article is to describe a protocol that provides suggestions and guides the clinical practice of writing cause-of-death statements for death certificates, autopsy reports, and other medical documents. The 16 members of the Autopsy Committee of the College of American Pathologists (CAP), Northfield, Ill, were appointed by the CAP officers based on demonstrated interest and expertise in autopsy performance and reporting. The committee perceived a need for specific instructions aimed at promoting consistency, accuracy, and completeness when writing cause-of-death statements. Development of a protocol was supported by CAP after approval by the CAP board of governors. The framework for the protocol was based on recommendations of the National Center for Health Statistics, Hyattsville, Md, with additional concepts added by the autopsy committee. The protocol for writing cause-of-death statements for natural causes is expected to foster consistency, accuracy, and completeness in the writing of cause-of-death statements. The quality of individual death certificates, autopsy reports, and national mortality data may improve through protocol usage. Application of the protocol principles should impose no ongoing costs at any user level because no new products or personnel are required for its application.

Autopsy↗

PubMed1997

Principles for including or excluding 'mechanisms' of death when writing cause-of-death statements.

OBJECTIVE: To develop principles and refined definitions designed to improve the content of cause-of-death statements regarding inclusion or exclusion of so-called mechanisms of death. DATA SOURCES: Survey of readily available instruction manuals and other literature regarding mechanisms of death and instructions for death certificate completion. DATA SYNTHESIS: Definitions and principles contained in the information sources were reviewed, and a set of specific principles, criteria, and definitions were written. These principles are consistent with, but are more extensive and practically applicable than, those found in each of the information sources surveyed and may be used to decide which conditions to report in cause-of-death statements. CONCLUSIONS: Mechanisms of death include a defined list of terminal events (such as asystole) and a larger group of nonspecific physiologic derangements (such as portal hypertension) and are differentiated by definition from nonspecific anatomic processes (such as cirrhosis). Three principles may be applied in individual cases. Principle 1 states that terminal events are not reported in cause-of-death statements. Principle 2 states that a nonspecific physiologic derangement or a nonspecific anatomic process should be reported if (1) it is a recognized, potentially fatal complication of the underlying cause of death; (2) it constitutes part of the sequence of conditions that led to the death of the patient in question; (3) it is not a symptom or sign; (4) its existence in the patient would not be apparent unless included and explicitly stated in the cause-of-death statement; (5) its inclusion does not constitute an oversimplification of the facts; and (6) an etiologically specific underlying cause of death is also reported. Principle 3 states that if the existence of the complication is obvious based on the underlying cause of death or another reported complication, it need not be reported.

Autopsy↗

PubMed2006

Consensus statement on the use of rituximab in patients with rheumatoid arthritis.

A large number of experts experienced in the treatment of rheumatoid arthritis were involved in formulating a consensus statement on the use of B cell-targeted treatment with rituximab in patients with rheumatoid arthritis. The statement was supported by data from randomised controlled clinical trials and the substantial literature on oncology. The statement underwent three rounds of discussions until its ultimate formulation. It should guide clinicians in the use of this newly approved biological agent in treating patients with rheumatoid arthritis.

Antibodies, Monoclonal↗

PubMed2000

Consensus statement on the live organ donor.

OBJECTIVE: To recommend practice guidelines for transplant physicians, primary care providers, health care planners, and all those who are concerned about the well-being of the live organ donor. PARTICIPANTS: An executive group representing the National Kidney Foundation, and the American Societies of Transplantation, Transplant Surgeons, and Nephrology formed a steering committee of 12 members to evaluate current practices of living donor transplantation of the kidney, pancreas, liver, intestine, and lung. The steering committee subsequently assembled more than 100 representatives of the transplant community (physicians, nurses, ethicists, psychologists, lawyers, scientists, social workers, transplant recipients, and living donors) at a national conference held June 1-2, 2000, in Kansas City, Mo. CONSENSUS PROCESS: Attendees participated in 7 assigned work groups. Three were organ specific (lung, liver, and kidney) and 4 were focused on social and ethical concerns (informed consent, donor source, psychosocial issues, and live organ donor registry). Work groups' deliberations were structured by a series of questions developed by the steering committee. Each work group presented its deliberations to an open plenary session of all attendees. This information was stored and shaped into a statement circulated electronically to all attendees for their comments, and finally approved by the steering committee for publication. The term consensus is not meant to convey universal agreement of the participants. The statement identifies issues of controversy; however, the wording of the entire statement is a consensus by approval of all attendees. CONCLUSION: The person who gives consent to be a live organ donor should be competent, willing to donate, free from coercion, medically and psychosocially suitable, fully informed of the risks and benefits as a donor, and fully informed of the risks, benefits, and alternative treatment available to the recipient. The benefits to both donor and recipient must outweigh the risks associated with the donation and transplantation of the living donor organ.

Health Status↗

PubMed2003

Confronting depression and suicide in physicians: a consensus statement.

OBJECTIVE: To encourage treatment of depression and prevention of suicide in physicians by calling for a shift in professional attitudes and institutional policies to support physicians seeking help. PARTICIPANTS: An American Foundation for Suicide Prevention planning group invited 15 experts on the subject to evaluate the state of knowledge about physician depression and suicide and barriers to treatment. The group assembled for a workshop held October 6-7, 2002, in Philadelphia, Pa. EVIDENCE: The planning group worked with each participant on a preworkshop literature review in an assigned area. Abstracts of presentations and key publications were distributed to participants before the workshop. After workshop presentations, participants were assigned to 1 of 2 breakout groups: (1) physicians in their role as patients and (2) medical institutions and professional organizations. The groups identified areas that required further research, barriers to treatment, and recommendations for reform. CONSENSUS PROCESS: This consensus statement emerged from a plenary session during which each work group presented its recommendations. The consensus statement was circulated to and approved by all participants. CONCLUSIONS: The culture of medicine accords low priority to physician mental health despite evidence of untreated mood disorders and an increased burden of suicide. Barriers to physicians' seeking help are often punitive, including discrimination in medical licensing, hospital privileges, and professional advancement. This consensus statement recommends transforming professional attitudes and changing institutional policies to encourage physicians to seek help. As barriers are removed and physicians confront depression and suicidality in their peers, they are more likely to recognize and treat these conditions in patients, including colleagues and medical students.

Adult↗

PubMed1995

The E.A.E.S. Consensus Development Conferences on laparoscopic cholecystectomy, appendectomy, and hernia repair. Consensus statements--September 1994. The Educational Committee of the European Association for Endoscopic Surgery.

Under the mandate of the Educational Committee of the European Association of Endoscopic Surgery (E.A.E.S.), three consensus development conferences (CDCs) were performed in order to assess the current status of the endoscopic surgical approaches for the treatment of cholelithiasis, appendicitis, and inguinal hernia. Consensus panels for the different disease states (10-13 members each) selected by the education committee on the basis of members' clinical expertise, academic activity, community influence, and geographical location weighed the evidence on the basis of published results according to the criteria for technology assessment: feasibility, efficacy, effectiveness, economy. Draft statements were prepared, discussed by the panels, and presented at plenary sessions of the 2nd European Congress of the E.A.E.S. in Madrid September 15-17, 1994. Following discussions final consensus statements were formulated to provide specific answers for each topic to a minimum of the following questions: 1. What stage of technological development is the endoscopic surgical procedure at (in September 1994)? 2. Is endoscopic surgery safe and feasible? 3. Is it beneficial to the patients? 4. Who should undergo endoscopic surgery? 5. What are the training recommendations? Laparoscopic cholecystectomy is the procedure of choice for symptomatic cholelithiasis. Laparoscopic appendectomy is presently at the efficacy stage of development, because most of the data on feasibility and safety originate from centers with special interest in endoscopic surgery: it is not yet the gold standard for acute appendicitis. Endoscopic hernia repair is presently a feasible alternative for conventional hernia repair if performed by experienced endoscopic surgeons. It appears to be efficacious in the short-term. The full text of the consensus panel's statements is given in this publication.

Appendectomy↗

PubMed2001

Antenatal corticosteroids revisited: repeat courses - National Institutes of Health Consensus Development Conference Statement, August 17-18, 2000.

OBJECTIVE: To provide health care providers, patients, and the general public with a responsible assessment of currently available data regarding the benefits and risks of repeat courses of antenatal corticosteroids. PARTICIPANTS: A non-Federal, non-advocate, 16-member panel representing the fields of obstetrics and gynecology, pediatrics, maternal and fetal medicine, neonatology, medical ethics, community health, pharmacology, psychology, and reproductive biology. In addition, 13 experts in these same fields presented data to the panel and to a conference audience of approximately 200. EVIDENCE: The literature was searched using MEDLINE and an extensive bibliography of references was provided to the panel. Experts prepared abstracts of their conference presentations with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference. The draft statement was made available on the World Wide Web immediately following its release at the conference and was updated with the panel's final revisions. CONCLUSIONS: The collective international data continue to support unequivocally the use and efficacy of a single course of antenatal corticosteroids using the dosage and interval of administration specified in the 1994 Consensus Development Conference report. The current benefit and risk data are insufficient to support routine use of repeat or rescue courses of antenatal corticosteroids in clinical practice. Clinical trials are in progress to assess potential benefits and risks of various regimens of repeat courses. Until data establish a favorable benefit-to-risk ratio, repeat courses of antenatal corticosteroids, including rescue therapy, should be reserved for patients enrolled in clinical trials.

Adrenal Cortex Hormones↗

PubMed1997

National Institutes of Health Consensus Development Conference Statement: Breast Cancer Screening for Women Ages 40-49, January 21-23, 1997. National Institutes of Health Consensus Development Panel.

OBJECTIVE: To provide health care providers, patients, and the general public with a responsible assessment of currently available data regarding the effectiveness of mammography screening for women ages 40-49. PARTICIPANTS: A non-Federal, nonadvocate, 12-member panel representing the fields of oncology, radiology, obstetrics and gynecology, geriatrics, public health, and epidemiology and including patient representatives. In addition, 32 experts in oncology, surgical oncology, radiology, public health, and epidemiology, presented data to the panel and to a conference audience of 1,100. EVIDENCE: The literature was searched through Medline and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed its conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised draft statement at the end of the conference. The final statement with a minority report was completed within several weeks after the conference. CONCLUSIONS: The Panel concludes that the data currently available do not warrant a universal recommendation for mammography for all women in their forties. Each woman should decide for herself whether to undergo mammography. Her decision may be based not only on an objective analysis of the scientific evidence and consideration of her individual medical history, but also on how she perceives and weighs each potential risk and benefit, the values she places on each, and how she deals with uncertainty. However, it is not sufficient just to advise a woman to make her own decision about mammograms. Given both the importance and the complexity of the issues involved in assessing the evidence, a woman should have access to the best possible relevant information regarding both benefits and risks, presented in an understandable and usable form. Information should be developed for women in their forties regarding potential benefits and risks to be provided to enable each woman to make the most appropriate decision. In addition, educational material to accompany this information should be prepared that will lead women step by step through the process of using such information in the best possible way for reaching a decision. For women in their forties who choose to have mammography performed, the costs of the mammograms should be reimbursed by third-party payors or covered by health maintenance organizations so that financial impediments will not influence a woman's decision. Additionally, a woman's health care provider must be equipped with sufficient information to facilitate her decisionmaking process. Therefore, educational material for physicians should be developed to assist them in providing the guidance and support needed by the women in their care who are making difficult decisions regarding mammography. The two panel members writing a minority report believed the risks of mammography to be overemphasized by the majority and concluded that the data did support a recommendation for mammography screening for all women in this age group and that the survival benefit and diagnosis at an earlier stage outweigh the potential risks.

Adult↗

PubMed2001

Sideline preparedness for the team physician: consensus statement.

The objective of the Sideline Preparedness Statement is to provide physicians who are responsible for making decisions regarding the medical care of athletes with guidelines for identifying and planning for medical care and services at the site of practice or competition. It is not intended as a standard of care and should not be interpreted as such. The Sideline Preparedness Statement is only a guide, and as such, is of a general nature, consistent with the reasonable, objective practice of the health care professional. Individual treatment will turn on the specific facts and circumstances presented to the physician at the event. Adequate insurance should be in place to help protect the physician, the athlete, and the sponsoring organization. The Sideline Preparedness Statement was developed by a collaboration of six major professional associations concerned about clinical sports medicine issues; they have committed to forming an ongoing project-based alliance to bring together sports medicine organizations to best serve active people and athletes. The organizations are: American Academy of Family Physicians, American Academy of Orthopaedic Surgeons, American College of Sports Medicine, American Medical Society for Sports Medicine, American Orthopaedic Society for Sports Medicine, and American Osteopathic Academy of Sports Medicine.

Athletic Injuries↗

PubMed2006

Consensus statement on injury definitions and data collection procedures in studies of football (soccer) injuries.

BACKGROUND: Variations in definitions and methodologies have created differences in the results and conclusions obtained from studies of football (soccer) injuries; this has made interstudy comparisons difficult. PROCEDURE: An Injury Consensus Group was established under the auspices of Fédération Internationale de Football Association Medical Assessment and Research Centre. Using a nominal group consensus model approach, a working document that identified the key issues related to definitions, methodology, and implementation was discussed by members of the group during a 2-day meeting. After this meeting, iterative draft statements were prepared and circulated to the members of the group for comment before the final consensus statement was produced. RESULTS: Definitions of injury, recurrent injury, severity, and training and match exposures in football, together with criteria for classifying injuries in terms of location, type, diagnosis, and causation are proposed. Proforma for recording players' baseline information, injuries, and training and match exposures are presented. Recommendations are made on how the incidence of match and training injuries should be reported and a checklist of issues and information that should be included in published reports of studies of football injuries is presented. CONCLUSIONS: The definitions and methodology proposed in the consensus statement will ensure that consistent and comparable results will be obtained from studies of football injuries.

Athletic Injuries↗

PubMed2004

Challenges in end-of-life care in the ICU: statement of the 5th International Consensus Conference in Critical Care: Brussels, Belgium, April 2003: executive summary.

OBJECTIVE: The purpose of the conference was to provide clinical practice guidance in end-of-life care in the ICU via answers to previously identified questions relating to variability in practice, inadequate predictive models for death, elusive knowledge of patient preferences, poor communication between staff and surrogates, insufficient or absent training of healthcare providers, the use of imprecise and insensitive terminology and incomplete documentation in the medical record. PARTICIPANTS: Presenters and jury were selected by the sponsoring organizations (American Thoracic Society, European Respiratory Society, European Society of Intensive Care Medicine, Society of Critical Care Medicine, Société de Réanimation de Langue Française). Presenters were experts on the question they addressed. Jury members were general intensivists without special expertise in the areas considered. Experts presented in an open session to jurors and other healthcare professionals. EVIDENCE: Experts prepared review papers on their specific topics in advance of the conference for the jury's reference in developing the consensus statement. CONSENSUS PROCESS: Jurors heard experts' presentations over 2 days and asked questions of the experts during the open sessions. Jury deliberation with access to the review papers occurred for 2 days following the conference. A writing committee drafted the consensus statement for review by the entire jury. The 5 sponsoring organizations reviewed the document and suggested revisions to be incorporated into the final statement. CONCLUSIONS: Strong recommendations for research to improve end-of-life care were made. The jury advocates a shared approach to end-of-life decision-making involving the caregiver team and patient surrogates. Respect for patient autonomy and the intention to honor decisions to decline unwanted treatments should be conveyed to the family. The process is one of negotiation, and the outcome will be determined by the personalities and beliefs of the participants. Ultimately, it is the attending physician's responsibility, as leader of the team, to decide on the reasonableness of the planned action. If a conflict cannot be resolved, an ethics consultation may be helpful. The patient must be assured of a pain-free death. The jury subscribes to the moral and legal principles that prohibit administering treatments specifically designed to hasten death. The patient must be given sufficient analgesia to alleviate pain and distress; if such analgesia hastens death, this "double-effect" should not detract from the primary aim to ensure comfort.

Belgium↗

PubMedDate not supplied

Management of osteoporosis in postmenopausal women: 2006 position statement of The North American Menopause Society.

OBJECTIVE: To update the evidence-based position statement published by The North American Menopause Society (NAMS) in 2002 regarding the management of osteoporosis in postmenopausal women. DESIGN: NAMS followed the general principles established for evidence-based guidelines to create this updated document. A panel of clinicians and researchers expert in the field of metabolic bone diseases and/or women's health were enlisted to review the 2002 NAMS position statement, compile supporting statements, and reach consensus on recommendations. The panel's recommendations were reviewed and approved by the NAMS Board of Trustees. RESULTS: Osteoporosis, whose prevalence is especially high among elderly postmenopausal women, increases the risk of fractures. Hip and spine fractures are associated with particularly high morbidity and mortality in this population. Given the health implications of osteoporotic fractures, the primary goal of osteoporosis therapy is to prevent fractures, which is accomplished by slowing or stopping bone loss, maintaining bone strength, and minimizing or eliminating factors that may contribute to fractures. The evaluation of postmenopausal women for osteoporosis risk requires a medical history, physical examination, and diagnostic tests. Major risk factors for postmenopausal osteoporosis (as defined by bone mineral density) include advanced age, genetics, lifestyle factors (such as low calcium and vitamin D intake, smoking), thinness, and menopause status. The most common risk factors for osteoporotic fracture are advanced age, low bone mineral density, and previous fracture as an adult. Management focuses first on nonpharmacologic measures, such as a balanced diet, adequate calcium and vitamin D intake, adequate exercise, smoking cessation, avoidance of excessive alcohol intake, and fall prevention. If pharmacologic therapy is indicated, government-approved options are bisphosphonates, a selective estrogen-receptor modulator, parathyroid hormone, estrogens, and calcitonin. CONCLUSIONS: Management strategies for postmenopausal women involve identifying those at risk of low bone density and fracture, followed by instituting measures that focus on reducing modifiable risk factors through lifestyle changes and, if indicated, pharmacologic therapy.

Evidence-Based Medicine↗

PubMedDate not supplied

The role of calcium in peri- and postmenopausal women: 2006 position statement of the North American Menopause Society.

OBJECTIVE: To update the evidence-based consensus opinion published by The North American Menopause Society (NAMS) in 2001 on the role of calcium in peri- and postmenopausal women. DESIGN: NAMS followed the general principles established for evidence-based guidelines to create this document. A panel of clinicians and researchers acknowledged to be experts in the field of calcium and women's health was enlisted to review the previous position statement and data published since then, compile supporting statements, and make recommendations. Their advice was used to assist the NAMS Board of Trustees in publishing this position statement. RESULTS: Adequate calcium intake (in the presence of adequate vitamin D status) has been shown to reduce bone loss in peri- and postmenopausal women and reduce fractures in postmenopausal women older than age 60 with low calcium intakes. Adequate calcium is considered a key component of any bone-protective therapeutic regimen. Calcium has also been associated with beneficial effects in several nonskeletal disorders, primarily hypertension, colorectal cancer, obesity, and nephrolithiasis, although the extent of those effects has not been fully elucidated. The calcium requirement rises at menopause. The target calcium intake for most postmenopausal women is 1,200 mg/day. Adequate vitamin D status, defined as 30 ng/mL or more of serum 25-hydroxyvitamin D (usually achieved with a daily oral intake of at least 400 to 600 IU), is required to achieve the nutritional benefits of calcium. The best source of calcium is food, and the best food source is dairy products. High-quality calcium supplements (taken in divided doses) are alternative sources for women unable to consume enough dietary calcium. There are no reported cases of calcium intoxication from food sources, and cases associated with supplements are rare (high intake levels of 2,150 mg/day have resulted in a 17% increase in renal calculi in one recent study, but not others). Because no accurate test to determine calcium deficiency exists, clinicians should focus instead on encouraging women to consume enough calcium to meet the recommended levels. CONCLUSIONS: The most definitive role for calcium in peri- and postmenopausal women is in bone health, but, like most nutrients, calcium has beneficial effects in many body systems. Based on the available evidence, there is strong support for the importance of ensuring adequate calcium intake in all women, particularly those in peri- or postmenopause.

Calcium↗

PubMed2006

Consensus statement on injury definitions and data collection procedures in studies of football (soccer) injuries.

Variations in definitions and methodologies have created differences in the results and conclusions obtained from studies of football injuries; this has made inter-study comparisons difficult. An Injury Consensus Group was established under the auspices of FIFA Medical Assessment and Research Centre. Using a nominal group consensus model approach, a working document that identified the key issues related to definitions, methodology and implementation was discussed by members of the group during a 2-day meeting. Following this meeting, iterative draft statements were prepared and circulated to members of the group for comment before the final consensus statement was produced. Definitions of injury, recurrent injury, severity and training and match exposures in football together with criteria for classifying injuries in terms of location, type, diagnosis and causation are proposed. Proforma for recording players' baseline information, injuries and training and match exposures are presented. Recommendations are made on how the incidence of match and training injuries should be reported and a checklist of issues and information that should be included in published reports of studies of football injuries is presented. The definitions and methodology proposed in the consensus statement will ensure that consistent and comparable results will be obtained from studies of football injuries.

Athletic Injuries↗

PubMed2005

First update of the international ASAS consensus statement for the use of anti-TNF agents in patients with ankylosing spondylitis.

OBJECTIVE: To update the international recommendations for use of anti-tumour necrosis factor (TNF) agents in the treatment of ankylosing spondylitis. METHODS: The published recommendations on anti-TNF treatment in ankylosing spondylitis formed the basis of the update. A questionnaire was sent to the ASAS (assessment in ankylosing spondylitis) members before the final decisions were agreed upon at an international meeting of the ASAS working group. RESULTS: Only minor changes to the original consensus statement were required. For the initiation of anti-TNF treatment, there should be: a diagnosis of definitive ankylosing spondylitis (normally based on modified New York criteria); active disease for at least four weeks, as defined by a sustained Bath ankylosing spondylitis disease activity index (BASDAI) of > or =4 on a 0-10 scale and expert opinion based on clinical findings; refractory disease, defined by failure of at least two non-steroidal anti-inflammatory drugs during a three month period, failure of intra-articular steroids (if indicated), and failure of sulfasalazine in patients with predominantly peripheral arthritis; and application of the usual precautions and contraindications for biological treatment. For monitoring anti-TNF treatment: both the ASAS core set for clinical practice and the BASDAI should be followed after the initiation of treatment. Discontinuation of anti-TNF treatment in non-responders should be considered after 6-12 weeks. Response is defined by improvement of at least 50% or 2 units (on a 0-10 scale) of the BASDAI. CONCLUSIONS: This updated consensus statement is recommended in guiding clinical practice and as a basis for developing national guidelines. Evaluation and regular update of this consensus statement is subject to further research by the ASAS group.

Antirheumatic Agents↗

PubMedDate not supplied

The Lugano statements on controlled clinical trials.

During a consensus conference in Lugano, Switzerland, 175 statements on controlled clinical trials were drafted by 47 representatives from academia, governmental registration agencies and industry in nine countries. Their opinion on these statements was similar to that of 47 'matched pairs' who did not attend the conference. Thus, the opinion of participants and non-participants appears to reflect the general opinion of those currently involved in designing, conducting and analysing controlled clinical trials. The Lugano statements give answers to the following questions: Is the controlled clinical trial in a crisis? What is the motivation to perform controlled clinical trials? Is it possible for a physician participating in a controlled clinical trial to act in the patient's best interest? Is it possible to obtain truly informed consent in a controlled clinical trial? When is it ethical to withhold active treatment in a controlled clinical trial? What are the controversial issues in the design of a good controlled clinical trial? Is there a double standard with respect to efficacy and adverse drug reactions in controlled clinical trials? What are the alternatives to controlled clinical trials and when should they be performed? How can sponsor bias be minimized? How should an ethics committee decide whether a controlled clinical trial is ethical? Should registration agencies become directly involved in the planning and conduct of controlled clinical trials? Do the declarations of Tokyo and Helsinki facilitate the conduct of ethically valid controlled clinical trials? Is it possible to create an international standard for the conduct and regulation of controlled clinical trials? Why do messages from controlled clinical trials filter into medicine so slowly? Is it possible to bridge the gap between controlled clinical trials and clinical reality? What are the costs of doing and not doing controlled clinical trials? When should drug companies decide to start a trial programme with a specific compound? Is there public hostility against controlled clinical trials? If so, how can it be reduced? The respondents almost unanimously felt that controlled clinical trials are a must: the public must be told that progress in medicine depends on controlled clinical trials, that patients often benefit from participating in them and that the alternative, practising in the face of constant uncertainty, is worse than the possible disadvantages related to the conduct of the trial.

Clinical Trials as Topic↗