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PubMed1998

Report of the Sinus Consensus Conference of 1996.

Retrospective data from sinus floor augmentation bone grafts were collected from 38 surgeons for 1007 sinus grafts that involved the placement of 2997 implants over a 10-year period, with the majority of the implants followed for 3 years or more postrestoration. There were 229 implant failures reported. Various root-form implants and grafting modalities were used. A consensus conference was organized to evaluate the data and reach a consensus on optimal treatment protocols. The complete database demonstrated a 90.0% success rate for implants placed in sinus grafts with at least 3 years of function. Differences in grafting materials, implant surfaces, and timing protocols were statistically analyzed. However, the database was so multivariate and multifactorial that it was difficult to draw definitive conclusions; these must await controlled prospective studies. The consensus conference therefore developed and voted on multiple consensus statements derived by committee review for bone graft materials, type of implants, timing for implant placement, failure analysis, radiographic analysis, indications/contraindications, prosthetics, and nomenclature. Several consensus statements were obtained, the most significant being that the sinus graft should now be considered a highly predictable and effective therapeutic modality.

Bone Substitutes↗
PubMed2000

[Revascularization of the corpora cavernosa in ischemia-induced erectile dysfunction].

Revascularization of the cavernous bodies (CB) has its place in a highly selected patient population as the only causal therapy for erectile dysfunction (ED) and provides an alternative to the implantation of alloplastic erectile aids. The indication for arterialization of the CB is currently only established when conservative treatment has failed. The most important criteria for the intervention are controversial: an age of under 50, an incidence of not more than two classical risk factors for impotence and the exclusion of diabetes mellitus. The leading revascularization procedure in German-speaking countries comprises arteriovenous shunting of the inferior epigastric artery with the dorsal vein and artery of the penis. A retrospective analysis of results is problematic due to the nonuniform indicational criteria, the multiplicity of applied revascularization procedures and a nonstandardized follow-up. Subjective assessment of improved erectility is the sole target criterion in the majority of studies. Therapeutic results range from 33 to 87% with regard to subjective success rates. Attempts to objectify the treatment results were made in only few of the studies and disclosed bypass patency in 44 to 92% one year after the intervention. The conclusions drawn at the last "Consensus Development Conference on Impotence" (CDCI) of the National Institutes of Health (NIH) in Washington have not lost their topicality in view of the great number of still unanswered questions. There the recommendation was made in 1992 to perform penile arterialization only in controlled prospective clinical trials. The European Urological Association (EUA) is currently organizing a Consensus Conference that will provide the framework for prospective studies that can serve as a basis for clarifying the open questions.

Aged↗
PubMed2001

Adjuvant therapy for breast cancer--results from the USA consensus conference.

The National Institutes of Health, USA sponsored a Consensus Development Conference on November 1-3, 2000 to review several major questions regarding the adjuvant treatment of breast cancer. A non-governmental group of oncology experts was selected to review clinical trial data and judge the evidence presented by 33 breast cancer researchers. Their conclusions resulted in the following recommendations: (1) Prognostic factors critical for determining risk of recurrence are age, axillary lymph node status, tumor size, histologic type and grade and hormone receptor status. (2) Tamoxifen, administered for 5 years, significantly improves long-term survival for women of all age groups with hormone receptor-positive tumors. Ovarian ablation also prolongs survival in premenopausal women. (3) Multi-agent chemotherapy of 4-6 months duration is associated with an improvement in survival in both hormone receptor-positive and -negative tumors. Anthracycline-containing regimens offer the greatest survival advantage. The role of taxanes is uncertain but they may be useful in selected patients with node-positive tumors. Women with small, node-negative tumors, women over age 70, and those with tumors of favorable histologic subtype (mucinous or tubular) may not require chemotherapy. (4) Adjuvant radiotherapy to the regional lymph nodes and chest wall following mastectomy is indicated for women with 4 or more axillary nodes. (5) Physicians should employ effective visual aids to help them present a complete and balanced view of the absolute benefits versus the side-effects of adjuvant treatments. Important avenues of future research were also discussed and suggestions were made.

Adult↗
PubMed1992

The prevention and management of urinary tract infections among people with spinal cord injuries. National Institute on Disability and Rehabilitation Research Consensus Statement. January 27-29, 1992.

The Urinary Tract Infection Consensus Conference brought together researchers, clinicians, and consumers to arrive at consensus on the best practices for preventing and treating urinary tract infections in people with spinal cord injuries; the risk factors and diagnostic studies that should be done; indications for antibiotic use; appropriate follow-up management; and needed future research. Urinary tract infection (UTI) was defined as bacteriuria (102 bacteria/ml of urine) with tissue invasion and resultant tissue response with signs and/or symptoms. Asymptomatic bacteriuria represents colonization of the urinary tract without symptoms or signs. Risk factors include: over-distention of bladder, vesicoureteral reflux, high pressure voiding, large post-void residuals, presence of stones in urinary tract, and outlet obstruction. Possible physiologic/structural, behavioral, and demographic risk factors were identified also. Indwelling catheterization, including suprapubic, and urinary diversion are the drainage methods most likely to lead to persistent bacteriuria. Infection risk is reduced with intermittent catheterization, but more severely disabled people who require catheterization by others are at greater risk for UTIs. Clean self-intermittent catheterization does not pose a greater risk of infection than sterile self-intermittent catheterization and is much more economic. However, care must be given to proper cleansing of reusable catheters. Quantitative urine-culture criteria for the diagnosis of bacteriuria include: catheter specimens from individuals on intermittent catheterization greater than or equal to 10(2) cfu/ml; clean-void specimens from catheter-free males using condom collection devices greater than or equal to 10(4) cfu/ml; and specimens from indwelling catheters of any detectable concentration. Dip stick screening tests may offer promise as an early warning system of UTI since they can be self-administered. Symptomatic UTI should be treated with antibiotics for 7 to 14 days. Longer courses have not been beneficial. In patients with symptomatic UTIs, it is not necessary to wait for the results of cultures before starting treatment. Asymptomatic bacteriuria need not be treated with antibiotics. There is little evidence presently to support the use of antibiotics to prevent infections. Following a recent episode of febrile UTI, possible contributing prior events should be reviewed. The upper tracts should be evaluated (imaging studies) to identify possible abnormalities. A common concern among people with spinal cord injuries is that physicians will alter bladder management programs without regard to lifestyle needs. Social/vocational flexibility may be more important to them than a state-of-the-art bladder management program. Future research should focus on obtaining more representative samples and investigate psycho-social-vocational implications as well as additional clinical-medical factors.

Anti-Bacterial Agents↗
PubMed2005

The future of multiple sclerosis therapies: redesigning multiple sclerosis clinical trials in a new therapeutic era.

Due to past success in testing and gaining regulatory approval for a variety of therapies in multiple sclerosis (MS), the conduct of future clinical trials has become increasingly problematic. An international workshop has met to discuss the issues facing the MS clinical trial community and to examine possible new strategies for the design of trials. Particular focus has been placed on trials that either avoid the use of a placebo because of ethical considerations or on designs that allow new therapies to be studied more rapidly or with fewer patients than needed in a conventional placebo-controlled trial. The discussions resulting from the workshop should provide a basis for the examination and implementation of innovative clinical trial designs in MS.

Adjuvants, Immunologic↗
PubMed1991

The Bethesda system for the reporting of cervical/vaginal cytology.

Use of the Papanicolaou smear for screening patients for cervical cancer has reduced the mortality of invasive squamous cell cervical cancer. The continuum of cellular abnormalities leading to invasive carcinoma have been carefully studied through cytologic evaluation. Through this process, terminology has changed, and the concept of cervical intraepithelial neoplasia has developed. Improved reporting of the cytologic abnormalities will not only lead to institution of appropriate therapy but also to a reduction in the number of false-negative results of cytologic studies. Improved communication between the cytopathologist and the attending clinician, as recommended by the Bethesda system, attempts to refine the process of appropriate patient care in the detection and treatment of cervical carcinoma and its precursor states.

Cell Biology↗
PubMed1988

Do consensus conferences work? A process evaluation of the NIH Consensus Development Program.

The purpose of this evaluation study is to identify problems and suggest modifications in the NIH Consensus Development Program. The current program consists of three-day conferences in which experts assess medical technologies for issues of efficacy, safety, conditions of use, and other related topics (e.g., costs and social impact). Eight consensus conferences held between 1980 and 1982 were studied in depth using a variety of methods; five of the conferences were investigated concurrently. In addition, archival material was examined for all but one of the 33 conferences held up to that time, and four planning meetings for future conferences were observed. The delay in publishing our findings provided an opportunity to examine the changes introduced by NIH; it also allowed us to avoid the criticism of numerous prior evaluations for finding fault with programs that are still developing. NIH adopted many of the recommendations in our evaluation report and has investigated others. Based on our evaluation and more recent evidence, however, we conclude that the major problem that was uncovered--selection bias, particularly with respect to the choice of questions and panelists--remains a significant threat to the credibility of the consensus process. More specifically, the results indicate that controversial issues cannot be properly addressed within the present conference format, although that was one of its major purposes. Recommendations for improving the consensus process are presented, as are their implications for a larger set of consensus activities that are currently being conducted.

Consensus Statements as Topic↗
PubMedDate not supplied

Diagnosis and management of dental caries throughout life.

OBJECTIVE: To provide health care providers, patients, and the general public with a responsible assessment of currently available data regarding the diagnosis and management of dental caries throughout life. PARTICIPANTS: A non-Federal, non-advocate, 13-member panel representing the fields of dentistry, epidemiology, genetics, medicine, oral biology, oral radiology, pathology, periodontics, public health, statistics, surgery, and including a public representative. In addition, 31 experts in these same fields presented data to the panel and to a conference audience of approximately 700. EVIDENCE: Presentations by experts; a systematic review of the dental research literature provided by the Agency for Healthcare Research and Quality; and an extensive bibliography of dental caries research papers, prepared by the National Library of Medicine. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: Answering predefined questions, the panel drafted a statement based on the scientific evidence presented in open forum and the scientific literature. The draft statement was read in its entirety on the final day of the conference and circulated to the experts and the audience for comment. The panel then met in executive session to consider these comments and released a revised statement at the end of the conference. The statement was made available on the World Wide Web at http://consensus.nih.gov immediately after the conference. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government. CONCLUSIONS: This Consensus Development Conference, the first sponsored by the NIH on dental caries, provided an excellent venue to describe the great success that has been achieved in reducing caries prevalence. More importantly, it provided a public forum to review both the strengths and weaknesses of current dental caries research and clinical procedures. Effective preventive practices, such as the use of fluoride, sugarless products, and dental sealants were reconfirmed and clinical studies to identify more conservative but more effective nonsurgical and surgical approaches are to be applauded. However, it was evident that current diagnostic practices are inadequate to achieve the next level of caries management in which noncavitated lesions are identified early so that they can be managed by nonsurgical methods. Some new and sensitive diagnostic approaches were presented to the panel, but concern was raised about the use of histological confirmation of caries presence as an appropriate gold standard. The resolution of these issues requires that surrogate markers, validated by histological confirmation, be developed. Once these surrogate markers of dental caries activity are validated, rapid advances in our understanding of the caries. In spite of optimism about the future, the panel was disappointed in the overall quality of the clinical data set that it reviewed. Far too many studies used weak research designs or were small or poorly described, and consequently had questionable validity. There was a clear impression that clinical caries research is underfunded, if not undervalued. Moreover, incomplete information on the natural history of dental caries, the inability to accurately identify early lesions and/or lesions that are actively progressing, and the absence of objective diagnostic methods are troubling. Several systematic reviews of the literature presented at the Consensus Development Conference concluded that the majority of the studies were inadequate, and it is clear that a major investment of research and training funds is required to seize the current opportunities. This is not to say that the diagnostic, preventive, and treatment techniques currently used do not work, but rather that earlier studies to support their efficacy do not meet current scientific standards. Indeed, given the dramatic improvements in reducing dental caries prevalence in the past 30 years, both consumers and health professionals should not depart from the practices which are likely to have contributed to this oral health improvement, including the use of a variety of fluoride products, dietary modification, pit and fissure sealant, improved oral hygiene, and regular professional care. In addition, pending new data, clinicians should apply both preventive and therapeutic interventions in the manner in which they have been studied. When solid confirmation of the effectiveness of promising new diagnostic techniques, nonsurgical treatments of noncavitated lesions, and conservative surgical interventions for cavitated lesions are obtained, dental health professionals and the public should embrace them rapidly in anticipation of attaining still higher levels of oral health. None of these anticipated advances will be achieved, however, in the absence of a progressive, third-party payment system that acknowledges its responsibility to compensate providers adequately to ensure that the next generation of conservative therapy can be enjoyed by the American people.

Behavior Therapy↗
PubMed2002

The 2001 Bethesda System: terminology for reporting results of cervical cytology.

OBJECTIVES: The Bethesda 2001 Workshop was convened to evaluate and update the 1991 Bethesda System terminology for reporting the results of cervical cytology. A primary objective was to develop a new approach to broaden participation in the consensus process. PARTICIPANTS: Forum groups composed of 6 to 10 individuals were responsible for developing recommendations for discussion at the workshop. Each forum group included at least 1 cytopathologist, cytotechnologist, clinician, and international representative to ensure a broad range of views and interests. More than 400 cytopathologists, cytotechnologists, histopathologists, family practitioners, gynecologists, public health physicians, epidemiologists, patient advocates, and attorneys participated in the workshop, which was convened by the National Cancer Institute and cosponsored by 44 professional societies. More than 20 countries were represented. EVIDENCE: Literature review, expert opinion, and input from an Internet bulletin board were all considered in developing recommendations. The strength of evidence of the scientific data was considered of paramount importance. CONSENSUS PROCESS: Bethesda 2001 was a year-long iterative review process. An Internet bulletin board was used for discussion of issues and drafts of recommendations. More than 1000 comments were posted to the bulletin board over the course of 6 months. The Bethesda Workshop, held April 30-May 2, 2001, was open to the public. Postworkshop recommendations were posted on the bulletin board for a last round of critical review prior to finalizing the terminology. CONCLUSIONS: Bethesda 2001 was developed with broad participation in the consensus process. The 2001 Bethesda System terminology reflects important advances in biological understanding of cervical neoplasia and cervical screening technology.

Female↗