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Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health.
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A National Cancer Institute Workshop on Microsatellite Instability for cancer detection and familial predisposition: development of international criteria for the determination of microsatellite instability in colorectal cancer.
In December 1997, the National Cancer Institute sponsored "The International Workshop on Microsatellite Instability and RER Phenotypes in Cancer Detection and Familial Predisposition," to review and unify the field. The following recommendations were endorsed at the workshop. (a) The form of genomic instability associated with defective DNA mismatch repair in tumors is to be called microsatellite instability (MSI). (b) A panel of five microsatellites has been validated and is recommended as a reference panel for future research in the field. Tumors may be characterized on the basis of: high-frequency MSI (MSI-H), if two or more of the five markers show instability (i.e., have insertion/deletion mutations), and low-frequency MSI (MSI-L), if only one of the five markers shows instability. The distinction between microsatellite stable (MSS) and low frequency MSI (MSI-L) can only be accomplished if a greater number of markers is utilized. (c) A unique clinical and pathological phenotype is identified for the MSI-H tumors, which comprise approximately 15% of colorectal cancers, whereas MSI-L and MSS tumors appear to be phenotypically similar. MSI-H colorectal tumors are found predominantly in the proximal colon, have unique histopathological features, and are associated with a less aggressive clinical course than are stage-matched MSI-L or MSS tumors. Preclinical models suggest the possibility that these tumors may be resistant to the cytotoxicity induced by certain chemotherapeutic agents. The implications for MSI-L are not yet clear. (d) MSI can be measured in fresh or fixed tumor specimens equally well; microdissection of pathological specimens is recommended to enrich for neoplastic tissue; and normal tissue is required to document the presence of MSI. (e) The "Bethesda guidelines," which were developed in 1996 to assist in the selection of tumors for microsatellite analysis, are endorsed. (f) The spectrum of microsatellite alterations in noncolonic tumors was reviewed, and it was concluded that the above recommendations apply only to colorectal neoplasms. (g) A research agenda was recommended.
Effective medical treatment of opiate addiction. National Consensus Development Panel on Effective Medical Treatment of Opiate Addiction.
OBJECTIVE: To provide clinicians, patients, and the general public with a responsible assessment of the effective approaches to treat opiate dependence. PARTICIPANTS: A nonfederal, nonadvocate, 12-member panel representing the fields of psychology, psychiatry, behavioral medicine, family medicine, drug abuse, epidemiology, and the public. In addition, 25 experts from these same fields presented data to the panel and a conference audience of 600. Presentations and discussions were divided into 3 phases over 2 1/2 days: (1) presentations by investigators working in the areas relevant to the consensus questions during a 2-day public session; (2) questions and statements from conference attendees during open discussion periods that are part of the public session; and (3) closed deliberations by the panel during the remainder of the second day and morning of a third day. The conference was organized and supported by the Office of Medical Applications of Research, National Institutes of Health. EVIDENCE: The literature was searched through MEDLINE and other National Library of Medicine and online databases from January 1994 through September 1997 and an extensive bibliography of 941 references was provided to the panel and the conference audience. Experts prepared abstracts for their presentations as speakers at the conference 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 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: Opiate dependence is a brain-related medical disorder that can be effectively treated with significant benefits for the patient and society, and society must make a commitment to offer effective treatment for opiate dependence to all who need it. All persons dependent on opiates should have access to methadone hydrochloride maintenance therapy under legal supervision, and the US Office of National Drug Control Policy and the US Department of Justice should take the necessary steps to implement this recommendation. There is a need for improved training for physicians and other health care professionals. Training to determine diagnosis and treatment of opiate dependence should also be improved in medical schools. The unnecessary regulations of methadone maintenance therapy and other long-acting opiate agonist treatment programs should be reduced, and coverage for these programs should be a required benefit in public and private insurance programs.
National Institutes of Health Consensus Development Conference Statement on Celiac Disease, June 28-30, 2004.
NIH consensus and state-of-the-science statements are prepared by independent panels of health professionals and public representatives on the basis of (1) the results of a systematic literature review prepared under contract with the Agency for Healthcare Research and Quality (AHRQ); (2) presentations by investigators working in areas relevant to the conference questions during a 2-day public session; (3) questions and statements from conference attendees during open discussion periods that are part of the public session; and (4) closed deliberations by the panel during the remainder of the second day and morning of the third. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government. The statement reflects the panel's assessment of medical knowledge available at the time the statement was written. Thus, it provides a "snapshot in time" of the state of knowledge on the conference topic. When reading the statement, keep in mind that new knowledge is inevitably accumulating through medical research.
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.
[Eradication of Helicobacter pylori in developing countries].
A NIH Consensus Conference recommended Helicobacter pylori eradication to all ulcer patients, based mainly on information coming from countries with a low prevalence of infection in general population. The epidemiological situation is different in developing countries, where a pandemic of H. pylori goes unchecked, and most people become infected at young age. It is possible that response to eradication therapies and reinfection rate were to be included among the differences between developed and developing countries, raising doubts about the worldwide applicability of NIH recommendations. Limited published evidence and our experience suggest that eradication therapies have a lower efficacy and reinfection rate is significantly higher in developing compared to developed countries. In spite of this, the risk of ulcer recurrence after H. pylori eradication is substantially reduced compared to antisecretory therapy. Model analysis to evaluate the cost-effectiveness of H. pylori eradication, using figures that probably include the clinical and costs situation of developing countries, suggests that also from an economic perspective H. pylori eradication should be the standard treatment for peptic ulcer disease in developing countries. Local studies must determine the best eradication therapy for a particular geographical location, and longer follow-up of eradicated patients is needed to determine the true reinfection rate.
The pathogenesis of atherosclerosis. An interpretive history of the cholesterol controversy, part IV: the 1984 coronary primary prevention trial ends it--almost.
As of the early 1980s, despite the wealth of evidence from experimental animal models, the extensive epidemiologic evidence, the powerful genetic evidence, and the strongly suggestive clinical intervention trial results, most clinicians still remained unpersuaded regarding the relevance of the lipid hypothesis. What was needed was a well-designed, large-scale, long-term, double-blind study demonstrating a statistically significant impact of treatment on coronary heart disease events. The National Institutes of Health (NIH) had laid the groundwork for such a study as early as 1970, but the study was not completed and the results published until 1984. This study, the Coronary Primary Prevention Trial, showed that treatment with a bile acid binding resin reduced major coronary events in hypercholesterolemic men by 19%, with a P value of 0.05. The NIH followed this up with a national Consensus Development Conference on Lowering Blood Cholesterol to Prevent Heart Disease. For the first time, the NIH now went on record advocating screening for hypercholesterolemia and urging aggressive treatment for those at high risk. The Institute initiated a national cooperative program to that end, the National Cholesterol Education Program. For the first time, preventing coronary heart disease became a national public health goal.
Prediction of bone mass change after parathyroidectomy in patients with primary hyperparathyroidism.
A major challenge in the management of primary hyperparathyroidism (pHPT) is the decision regarding which patients should undergo parathyroidectomy (PTX), although the Consensus Development Conference of the NIH has proposed guidelines for the indication of surgery. In the present study, changes in bone mineral density (BMD) after PTX were compared between pHPT patients who did and did not meet the NIH criteria, and we further tried to predict the BMD change after PTX from preoperative parameters. The subjects were 44 pHPT patients (30 women and 14 men) who had had successful PTX. Lumbar and radial BMD were measured before and 1 yr after PTX by dual energy x-ray absorptiometry and single photon absorptiometry, respectively. Average annual percent increases in lumbar and radial BMD after PTX were 12.2 +/- 1.4% and 11.6 +/- 1.6% (mean +/- SEM), respectively, and those net increases were 0.0803 +/- 0.0008 and 0.0484 +/- 0.0006 g/cm2, respectively. There were no significant differences in percent or net changes in either radial or lumbar BMD after PTX between the groups divided according to each of the NIH criteria, such as age (> or =50 and <50 yr), serum calcium level (> or =12 and <12 mg/dL) or the existence of urinary stones (presence and absence). On the other hand, when the subjects were divided on the basis of radial BMD (above and below a z-score of -2), the annual percent and net increases in lumbar BMD and percent increase in radial BMD after PTX were significantly higher in the group with the lower z-score. Next, patients were divided into two groups with and without the indication of PTX based on NIH guidelines. Twenty-nine patients had the surgical indication by meeting one or more of these criteria and 15 patients had no indication without meeting any of the criteria. There were no significant differences between the two groups in annual percent or net changes in radial or lumbar BMD after PTX. A stepwise multiple regression analysis revealed that serum alkaline phosphatase level and the severity of cortical bone mass reduction were the best predictors of both percentage and net changes in lumbar BMD, with high determination coefficients (r2 > 0.7). In conclusion, a considerable increase in BMD could be obtained after PTX even in patients without surgical indication from the NIH. Alkaline phosphatase and the severity of cortical bone mass reduction are clinically useful for predicting the changes in lumbar BMD after PTX. The present findings provide a useful clue for the indication of surgery in pHPT.
International consensus recommendations. Summary statement and additional suggested guidelines. European Consensus Conference, November 1991. American College of Chest Physicians consensus statement of 1995. International Consensus Statement, 1997.
Since the NIH Consensus Conference in 1986, the developments in the field of prevention and treatment of venous thromboembolism were mainly characterized by a more specific and extended use of new prophylactic agents such as low-molecular-weight heparins as well as the perception that out-patients may be at risk for thromboembolic complications, too. Therefore, in 1991 and 1995, consensus conferences were held in Europe and North America in order to analyze the risk constellation of various patient populations and to give recommendations for primary prophylaxis and treatment of thromboembolic complications. The most recent, the 1997 International Consensus Recommendations are also discussed.
NIH panels analyze issues on technology.
Experts at NIH's "consensus development" technology assessment conferences study a wide range of issues and make recommendations to help guide users of medical technologies.
The role of tumor markers in the management of colorectal cancer.
Among the tumor-associated antigens evaluated for the diagnosis and management of cancer, carcinoembryonic antigen (CEA) is the only established and clinically useful tumor marker for colorectal cancer and other CEA-producing tumors. Because of the exhaustive studies in the past decade, a consensus development conference was held at NIH in September 1980, to address the issue concerning the role of CEA as a marker in the management of cancer. This conference concluded that the use of regular and sequential assays of blood CEA is the best noninvasive technique for postoperative surveillance of patients to detect disseminated recurrence of colorectal cancer. The CEA level can serve as an indicator of successful or incomplete resection, and is useful in monitoring the effect of chemotherapy or radiotherapy. CEA can also provide a useful estimate of prognosis. CEA is neither sensitive nor specific enough to be used in routine screening for possible malignancy in an asymptomatic population. Nor can this test independently establish a diagnosis of cancer, but it can be used as an adjunct to clinical staging methods in known cancer patients. Radioimmunodetection and radioimmunotherapy with anti-CEA antibodies are currently being evaluated. Study of the pathophysiology and metabolism of CEA is needed. CEA remains the prototype tumor marker and is a valuable comparative tool, when investigating the clinical value of other newly developed tests for tumor markers.
A procedure for developing a quality-of-life measure for epilepsy surgery patients.
In 1990, the NIH Consensus Conference Panel on epilepsy surgery called for the development and use of reliable and valid health-related quality-of-life (HRQOL) measures in epilepsy surgery studies. A HRQOL measure for epilepsy surgery patients has been developed and evaluated. The procedure, which could also be used to develop HRQOL measures for other neurological diseases, entails the following steps: (a) specify desired characteristics of the measure; (b) identify relevant HRQOL areas by reviewing the literature; (c) assemble generic core items and disease-specific supplementary items; (d) pilot test and revise the measure; (e) administer revised measure items to a large sample of epilepsy surgery patients; (f) perform item analysis to evaluate hypothesized item placement within scales; and (g) assess the reliability and validity of the scales. The product of this process, the Epilepsy Surgery Inventory (ESI)-55, is a self-report measure of 11 dimensions of HRQOL. It is brief, comprehensive, and reliable; preliminary evidence supports its validity.
Update: NIH consensus conference. Gastrointestinal surgery for severe obesity.
The 1991 Consensus Development Panel was instrumental both in establishing criteria for selection of patients for surgical treatment and in recognition of operations that have been shown to be safe and reasonably effective in the long term. The Panel may have been premature in endorsement of any form of banded gastroplasty because the long-term weight loss results of these procedures are frequently disappointing. It seems likely that a consensus panel on the same subject would be worthwhile in the next decade to carefully evaluate such procedures as biliopancreatic bypass and the various laparoscopic techniques for gastric banding. In 1996 surgery remains the only effective treatment for patients with medically severe (morbid) obesity.
[Current status of adjuvant therapy in patients with colorectal cancer: report and commentary on the Consensus Conference, 16-18 April 1990, National Cancer Institute, Bethesda, Maryland].
This is a report on the Consensus Development Conference on adjuvant therapy for patients with colorectal carcinoma, which was held at the National Cancer Institute of the National Institutes of Health (NIH) in Bethesda, Maryland between April 16th and 18th 1990. Based on statistically significant results of a clinical trial adjuvant therapy with 5-fluorouracil (5-FU) and levamisole was recommended outside controlled clinical studies for patients with Dukes C colon carcinoma, but because no optimal form of adjuvant therapy yet exists there is still the need for further trials. No recommendations were given for patients with Dukes B colon carcinoma. For patients with Dukes B + C rectal cancer combined radiation therapy and 5-FU-based chemotherapy was considered "standard therapy" according to the consensus panel, but this recommendation seems to be still worth discussing. Since there is need of further evaluation of newly-recognized prognostic factors and also to optimize adjuvant strategies the panel stated that further prospective randomized studies are warranted. Hence, the establishment of a multicentre study group also in Austria appears to be an essential application of such trials in order to contribute towards ameliorating the prognosis of patients with colorectal carcinoma.
Emerging concepts in celiac disease.
PURPOSE OF REVIEW: There has been an explosion in knowledge about celiac disease (CD) in the last decade based on the availability of serologic screening tests and the elucidation of some of the important disease susceptibility genes. What has been discovered is that CD is among the most common inherited diseases with a worldwide prevalence of almost 1% of the population. Also, there has been a tremendous expansion of the possible clinical presentations in patients with CD, many of them predominantly or even exclusively extraintestinal. Over the last year, both the North American Society of Pediatric Gastroenterology and Nutrition, and the NIH, through the mechanism of a consensus development conference held in May 2004, have published guidelines outlining the current state of knowledge and the areas where more research is needed. RECENT FINDINGS: This review will stress the most recent findings in CD in the areas of genetics, pathogenesis, epidemiology, screening and diagnosis, and natural history. It will stress the importance of HLA DQ2 and DQ8 as disease susceptibility genes, and the interaction of the environmental triggers (gliadins and glutenins) with these gene products to trigger the immunologic response in the gut that is responsible for the pattern of injury. Recent reports that stress the importance of screening high-risk groups (i.e. siblings of index cases and first degree relatives, patients with Type I diabetes, patients with Downs syndrome, patients with IgA deficiency) will be highlighted. The identification of the most sensitive and specific screening tests will be summarized with an explanation of special situations that affect the interpretation of these tests. Finally, the long-term morbidities associated with CD will be characterized supporting the case for early diagnosis and treatment. SUMMARY: The implications of these recent findings are of tremendous importance for both pediatricians and internists. Screening of high-risk groups, and of patients with the common symptoms of irritable bowel syndrome, iron deficiency anemia, unexplained arthritis, and even chronic elevations of aminotransferases is becoming the accepted standard of practice. Much research remains to be done to further refine our understanding of CD, and to devise more effective strategies for treatment, compliance, and prevention of long-term complications.
Treatment of osteopenia secondary to primary hyperparathyroidism.
A major challenge in the management of primary hyperparathyroidism (pHPT) is the decision regarding which patients should undergo parathyroidectomy (PTX). although the Consensus Development Conference of the National Institutes of Health (NIH) has proposed guidelines for the indication of surgery. We found that PTX brings about increases in radial and lumbar BMD values as high as 10% in virtually all pHPT patients including postmenopausal women and those without an indication for surgery based on NIH criteria. Serum alkaline phosphatase (ALP) level and the severity of cortical bone mass reduction are clinically useful for predicting the changes in lumbar BMD after PTX. The present findings provide a useful clue for the indication of surgery in pHPT, and seem to warrant a more extended indication than that of the NIH. We also described the recent progress in studies on calcium-sensing receptor (CaR), and discussed the possibility of bone mass recovery by medical treatment of pHPT with a newly introduced CaR agonist ('calcimimetics').