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PubMed2000

[Radiotherapy and chemotherapy in the treatment of cancer of the rectum].

The North American consensus conference held in 1990 concluded that the best currently available adjuvant treatment for cancer of the rectum (T3, N1 to N3) was postoperative combination radiotherapy and chemotherapy. In 1994, the consensus conference held in Paris concluded that the benefit observed after preoperative irradiation warranted assessment of the effect of preoperative radiochemotherapy. To decide between these two consensus conclusions, it would be most logical to compare preoperative radiotherapy with postoperative radiochemotherapy in a group of patients with similar echo-endoscopic or imaging findings.

Antimetabolites, Antineoplastic↗
PubMed2002

National Depressive and Manic-Depressive Association consensus statement on the use of placebo in clinical trials of mood disorders.

A consensus conference on the use of placebo in mood disorder studies consisted of expert presentations on bioethics, biostatistics, unipolar depression, and bipolar disorder. Work groups considered evidence and presented statements to the group. Although it was not possible to write a document for which there was complete agreement on all issues, the final document incorporated input from all authors. There was consensus that placebo has a definite role in mood disorder studies. Findings of equivalence between a new drug and standard treatment in active control studies is not evidence of efficacy unless the new drug is also significantly more effective than placebo. Add-on studies in which patients are randomized to standard therapy plus the investigational drug or standard therapy plus placebo are especially indicated for high-risk patients. Mood disorders in elderly and pediatric patients are understudied, and properly designed trials are urgently needed. Research is needed on the ethical conduct of studies to limit risks of medication-free intervals and facilitate poststudy treatment. Patients must fully understand the risks and lack of individualized treatment involved in research.

Bipolar Disorder↗
PubMed2006

Chronic graft-versus-host disease: implications of the National Institutes of Health consensus development project on criteria for clinical trials.

Chronic graft-versus-host disease (GVHD) has been a difficult problem to address and clinical research in this area lags behind other innovations in hematopoietic stem cell transplantation (HCT). Recently the international transplant community has focused more on chronic GVHD. This new focus is well represented by the development of the National Institutes of Health sponsored chronic GVHD consensus project, which has unified the transplant community's approach to chronic GVHD through the activities of focused working groups. From December 2005 through May 2006, a series of consensus documents have been published addressing the areas of diagnosis and staging, histopathology, strategies for the development and validation of biomarkers, response criteria, ancillary therapy and supportive care and the design of clinical trials. This paper summarizes and discusses these reports, focusing specifically on diagnosis and scoring and response criteria. Although these documents represent a huge effort by the research community, they must be prospectively implemented and validated. These new criteria should advance the standards and uniformity of chronic GVHD clinical research. The ultimate success of this project is dependent on whether these recommendations move the field forward. This is an opportunity for the transplant community to unite and make a significant impact in chronic GVHD.

Chronic Disease↗
PubMed2003

Symptom management in cancer: pain, depression and fatigue: State-of-the-Science Conference Statement.

NIH Consensus Statements are prepared by a nonadvocate, non-Federal panel of experts, based on (1) presentations by investigators working in 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 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.

Analgesics↗
PubMedDate not supplied

NIH-FDA Analgesic Drug Development Workshop: translating scientific advances into improved pain relief.

Analgesic drug development as currently undertaken is limited by a number of factors that contribute to the paucity of new analgesics introduced into clinical practice despite marked advances in delineating of the molecular-genetic mechanisms contributing to acute and chronic pain. The participants in this workshop explored the unmet need in analgesia and recommended strategies for enhancing analgesic drug development in the future. The workshop concluded that translating scientific advances into improved pain relief will require new thinking and a cooperative effort among the pharmaceutical industry, regulatory agencies, funding agencies, the biomedical research community, professional societies and clinicians. The workshop also recommended that a better understanding of the epidemiology of pain could contribute to improvement in clinical trial methodology and outcome measures.

Analgesics↗
PubMed2005

Estrogens and progestins: background and history, trends in use, and guidelines and regimens approved by the US Food and Drug Administration.

The US Food and Drug Administration (FDA) approved marketing of diethylstilbestrol in 1941 and conjugated equine estrogens (CEE) in 1942 for treatment of menopausal symptoms. Estrogen sales doubled and tripled in the mid-1960s to mid-1970s, until 1975, when reports of increased endometrial cancer in estrogen users resulted in a dramatic decline. Estrogen use increased again, with evidence of protective effects of progestins on estrogen-induced endometrial changes, combined with a 1982 report that Premarin (conjugated estrogen tablets; Wyeth Pharmaceuticals, Philadelphia, PA) retained bone mass and a 1984 National Institutes of Health (NIH) Consensus Conference on Osteoporosis statement that estrogens were the most effective means for preventing bone loss. Despite conflicting reports in 1985 regarding the relation between estrogens and coronary heart disease (CHD), many published observations of reduced CHD risk in estrogen users--reinforced by clinical trial findings in 1995 of favorable lipoprotein changes in women assigned to CEE with or without a progestin--promoted increased use through the 1990s. By 2001, approximately 15 million US women were using estrogen therapy, with or without progestins. The 2002 Women's Health Initiative (WHI) report of greater harm than benefit of combined CEE plus a progestin resulted in a precipitous decrease in estrogen and progestin use and a serious reevaluation of menopausal hormone therapy, as well as increased interest in alternative approaches to managing menopausal symptoms, including use of "bioidentical" hormones. FDA guidelines regarding treatment indications for vasomotor symptoms, vaginal atrophy, and osteoporosis prevention have resulted in approval of several estrogen (and progestin) formulations, doses, and routes of administration, thereby providing many options for women who seek conventional therapy.

Drug Approval↗
PubMed2006

National Institutes of Health State-of-the-Science Conference Statement : Preventing Violence and Related Health-Risking, Social Behaviors in Adolescents, October 13-15, 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 and behavioral research.

Adolescent↗
PubMed2005

Report of the National Heart, Lung, and Blood Institute working group on outcomes research in cardiovascular disease.

The National Heart, Lung, and Blood Institute convened a working group on outcomes research in cardiovascular disease (CVD). The working group sought to provide guidance on research priorities in outcomes research related to CVD. For the purposes of this document, "outcomes research" is defined as investigative endeavors that generate knowledge to improve clinical decision making and healthcare delivery to optimize patient outcomes. The working group identified the following priority areas: (1) national surveillance projects for high-prevalence CV conditions; (2) patient-centered care; (3) translation of the best science into clinical practice; and (4) studies that place the cost of interventions in the context of their real-world effectiveness. Within each of these topics, the working group described examples of initiatives that could serve the Institute and the public. In addition, the group identified the following areas that are important to the field: (1) promotion of the use of existing data; (2) facilitation of collaborations with other federal agencies; (3) investigations into the basic science of outcomes research, with an emphasis on methodological advances; (4) strengthening of appropriate study sections with individuals who have expertise in outcomes research; and (5) expansion of opportunities to train new outcomes research investigators. The working group concluded that a dedicated investment in CV outcomes research could directly improve the care delivered in the United States.

Cardiovascular Diseases↗
PubMed2003

Summary and recommendations of a National Cancer Institute workshop on issues limiting the clinical use of Monte Carlo dose calculation algorithms for megavoltage external beam radiation therapy.

Due to the significant interest in Monte Carlo dose calculations for external beam megavoltage radiation therapy from both the research and commercial communities, a workshop was held in October 2001 to assess the status of this computational method with regard to use for clinical treatment planning. The Radiation Research Program of the National Cancer Institute, in conjunction with the Nuclear Data and Analysis Group at the Oak Ridge National Laboratory, gathered a group of experts in clinical radiation therapy treatment planning and Monte Carlo dose calculations, and examined issues involved in clinical implementation of Monte Carlo dose calculation methods in clinical radiotherapy. The workshop examined the current status of Monte Carlo algorithms, the rationale for using Monte Carlo, algorithmic concerns, clinical issues, and verification methodologies. Based on these discussions, the workshop developed recommendations for future NCI-funded research and development efforts. This paper briefly summarizes the issues presented at the workshop and the recommendations developed by the group.

Algorithms↗
PubMed1984

A multicenter retrospective review of the mandibular staple bone plate.

The mandibular staple bone plate, herein referred to as the staple, has been used as a reconstructive device to improve mandibular function for more than a decade. This report presents the clinical and radiographic findings of a retrospective survey of 160 patients from three separate practices over an eight-year period (1975-1983). The criteria established at the 1978 NIH-Harvard Consensus Development Conference on Dental Implants were used to evaluate results. The study also evaluates experiences with other procedures used in conjunction with the staple.

Bone Plates↗
PubMed1999

Breast conservation therapy in the United States following the 1990 National Institutes of Health Consensus Development Conference on the treatment of patients with early stage invasive breast carcinoma.

BACKGROUND: A National Institutes of Health (NIH) Consensus Development Conference on the treatment of patients with early stage invasive breast carcinoma, held in June 1990, recommended breast conservation therapy for the majority of women with Stage I or II breast carcinoma. The authors evaluated the national use of breast conservation therapy before and after the conference to determine whether the conference had had an impact on utilization. METHODS: Women with Stage I or II breast carcinoma (n = 109,880), diagnosed during the years 1983-1995, were identified via 9 population-based cancer registries of the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute. The likelihood of breast conservation surgery versus mastectomy and, among women who underwent breast conservation surgery, the likelihood of postoperative radiation therapy versus none, were assessed for 3 time periods (January 1983 to April 1985, May 1985 to June 1990, and July 1990 to December 1995). Associations between the use of breast conservation surgery or postoperative radiotherapy according to patient stage, age, race, and region were compared among women diagnosed before and after the NIH Consensus Development Conference. RESULTS: From 1985 (the year that the U.S. randomized controlled trial demonstrating equivalent efficacy between breast conservation therapy and mastectomy was published) through 1989, approximately 35% of women with Stage I and 19% of women with Stage II breast carcinoma underwent breast conservation surgery; these percentages remained constant throughout this period. Beginning in 1990, the year of the NIH Consensus Development Conference, the use of breast conservation surgery increased in each subsequent year; by 1995, 60% of women with Stage I and 39% of women with Stage II breast carcinoma received such treatment. However, regional variation in use was observed (Stage I, range 41.4-71.4% for 1995) and no registry reported breast conservation therapy for the majority of women with Stage II disease (range, 23.8-48.0%). The use of postoperative radiotherapy for women who underwent breast conservation surgery was similar in the periods before and after the conference. CONCLUSIONS: Although breast conservation therapy was performed more frequently following the NIH Consensus Development Conference, variation in use by region of the U.S. suggests the continued presence of barriers to widespread adoption of the recommendations formulated at the conference.

Adult↗