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Osteoporosis prevention, diagnosis, and therapy.

OBJECTIVES: To clarify the factors associated with prevention, diagnosis, and treatment of osteoporosis, and to present the most recent information available in these areas. PARTICIPANTS: From March 27-29, 2000, a nonfederal, nonadvocate, 13-member panel was convened, representing the fields of internal medicine, family and community medicine, endocrinology, epidemiology, orthopedic surgery, gerontology, rheumatology, obstetrics and gynecology, preventive medicine, and cell biology. Thirty-two experts from these fields presented data to the panel and an audience of 699. Primary sponsors were the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institutes of Health Office of Medical Applications of Research. EVIDENCE: MEDLINE was searched for January 1995 through December 1999, and a bibliography of 2449 references provided to the panel. Experts prepared abstracts for presentations with relevant literature citations. Scientific evidence was given precedence over anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed conclusions based on evidence presented in open forum and the literature. The panel composed a draft statement, which was read and circulated to the experts and the audience for public discussion. The panel resolved conflicts and released a revised statement at the end of the conference. The draft statement was posted on the Web on March 30, 2000, and updated with the panel's final revisions within a few weeks. CONCLUSIONS: Though prevalent in white postmenopausal women, osteoporosis occurs in all populations and at all ages and has significant physical, psychosocial, and financial consequences. Risks for osteoporosis (reflected by low bone mineral density [BMD]) and for fracture overlap but are not identical. More attention should be paid to skeletal health in persons with conditions associated with secondary osteoporosis. Clinical risk factors have an important but poorly validated role in determining who should have BMD measurement, in assessing fracture risk, and in determining who should be treated. Adequate calcium and vitamin D intake is crucial to develop optimal peak bone mass and to preserve bone mass throughout life. Supplementation with these 2 nutrients may be necessary in persons not achieving recommended dietary intake. Gonadal steroids are important determinants of peak and lifetime bone mass in men, women, and children. Regular exercise, especially resistance and high-impact activities, contributes to development of high peak bone mass and may reduce risk of falls in older persons. Assessment of bone mass, identification of fracture risk, and determination of who should be treated are the optimal goals when evaluating patients for osteoporosis. Fracture prevention is the primary treatment goal for patients with osteoporosis. Several treatments have been shown to reduce the risk of osteoporotic fractures, including those that enhance bone mass and reduce the risk or consequences of falls. Adults with vertebral, rib, hip, or distal forearm fractures should be evaluated for osteoporosis and given appropriate therapy.

Adult↗

Carrier screening for cystic fibrosis among Maryland obstetricians before and after the 1997 NIH Consensus Conference.

The 1997 National Institutes of Health (NIH) Consensus Conference on Cystic Fibrosis (CF) testing recommended that carrier screening be offered to all pregnant women and couples planning a pregnancy. We surveyed 492 Maryland Ob-Gyns before and after the consensus conference to: (1) assess whether obstetricians changed their practice regarding CF carrier testing, and (2) identify the factors associated with changing practice patterns, including awareness of the statement, and knowledge about CF. Fifty-six percent (275) responded to the first mail questionnaire and 107 obstetricians responded to both questionnaires. In 1998, only 18% of respondents to the second questionnaire were familiar with the NIH statement, but 43% reported discussing testing with patients with no family history, a significant increase from 1997, when only 20% reported discussing testing. Less than one-third correctly answered six multiple-choice knowledge questions about CF and carrier testing. In multivariate analysis, knowledge and familiarity with the NIH consensus statement were not associated with beginning to discuss CF carrier testing after the CF conference with their patients without a family history.

Adult↗

Effect of corticosteroids for fetal maturation on perinatal outcomes. NIH Consensus Development Panel on the Effect of Corticosteroids for Fetal Maturation on Perinatal Outcomes.

OBJECTIVE: To develop a consensus on the use of antenatal corticosteroids for fetal maturation in preterm infants. PARTICIPANTS: A nonfederal, nonadvocate, 16-member consensus panel including representatives from neonatology, obstetrics, family medicine, behavioral medicine, psychology, biostatistics, and the public; 19 experts in neonatology, obstetrics, and pharmacology presented data to the consensus panel and a conference audience of approximately 500. EVIDENCE: An extensive bibliography of references was produced for the consensus panel and the conference audience using a variety of on-line databases including MEDLINE. The consensus panel met several times prior to the conference to review the literature. It also commissioned an updated meta-analysis, a neonatal registry review, and an economic analysis that were presented at the conference. The experts prepared abstracts for distribution at the conference, presented data, and answered questions from the panel and audience. The panel evaluated the strength of the scientific evidence using the grading system developed by the Canadian Task Force on the Periodic Health Examination and adapted by the US Preventive Services Task Force. CONSENSUS: The consensus panel, answering predefined consensus questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. CONSENSUS STATEMENT: The consensus panel composed a draft statement that was read in its entirety at the conference for comment. The panel released a revised statement at the end of the conference and finalized the revisions a few weeks after the conference. CONCLUSIONS: Antenatal corticosteroid therapy is indicated for women at risk of premature delivery with few exceptions and will result in a substantial decrease in neonatal morbidity and mortality, as well as substantial savings in health care costs. The use of antenatal corticosteroids for fetal maturation is a rare example of a technology that yields substantial cost savings in addition to improving health.

Betamethasone↗

The NIH Consensus concept of chronic prostatitis/chronic pelvic pain syndrome compared with traditional concepts of nonbacterial prostatitis and prostatodynia.

The new National Institutes of Health (NIH) consensus classification identifies chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) based on the presence or absence of leukocytes in expressed prostatic secretions (EPS), postprostatic massage urine (VB3), or seminal fluid analysis. The purpose of this review is to determine the effect of the new classification on the proportion of symptomatic patients diagnosed with inflammation. We compare and contrast the new consensus classification with the traditional classification of prostatitis syndromes, then review how these changes effect patient classification in our clinical practice. Thorough clinical and microbiologic examination of 140 patients attending the University of Washington Prostatitis Clinic included evaluation of first void urine, mid-stream urine, EPS, VB3, and semen specimens. Inflammation was documented in 111 (26%) of 420 samples including 39 EPS samples, 32 VB3 samples, and 40 SFA specimens. Of the 140 patients, 73 (52%) had inflammatory CP/CPPS according to the NIH consensus criteria, but only 39 (28%) had nonbacterial prostatitis according to traditional EPS criteria (P < 0.001). The new NIH consensus concept of inflammatory CP/CPPS includes almost twice as many patients as the traditional category of nonbacterial prostatitis.

Chronic Disease↗

Infectious disease testing for blood transfusions. NIH Consensus Development Panel on Infectious Disease Testing for Blood Transfusions.

OBJECTIVE: To provide physicians and other transfusion medicine professionals with a current consensus on infectious disease testing for blood transfusions. PARTICIPANTS: A nonfederal, nonadvocate, 12-member consensus panel representing the fields of hematology, infectious disease, transfusion medicine, epidemiology, and biostatistics and a public representative. In addition, 23 experts in hematology, cardiology, transfusion medicine, infectious disease, and epidemiology presented data to the consensus panel and a conference audience of 450. 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: The panel, answering predefined consensus questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. CONSENSUS STATEMENT: 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. CONCLUSIONS: The serum alanine aminotransferase test should be discontinued as a surrogate marker for blood donors likely to transmit posttransfusion non-A, non-B hepatitis infection since specific hepatitis C antibody testing has eliminated more than 85% of these cases. Antibody to hepatitis B core antigen testing should continue as it may prevent some cases of posttransfusion hepatitis B; it may also act as a surrogate marker for human immunodeficiency virus (HIV) infection in donors and may prevent a small number of cases of transfusion-transmitted HIV infection. Syphilis testing should continue until adequate data can determine its effect on the rarity of transfusion-transmitted syphilis. Vigilant public health surveillance is critical in responding to emerging infectious disease threats to the blood supply.

Alanine Transaminase↗

Cystic fibrosis and the National Institutes of Health consensus statement: are obstetrician-gynecologists ready to comply?

OBJECTIVE: To determine if obstetrician-gynecologists are ready to comply with the April 1997 National Institutes of Health (NIH) consensus statement regarding carrier screening for cystic fibrosis. METHODS: A multiple-choice questionnaire was mailed to all active North Carolina nonfederal physicians with a primary specialty of obstetrics and gynecology. Ten questions surveyed the participants' knowledge about cystic fibrosis. RESULTS: Two hundred eighty-six surveys were returned for a response rate of 30.4%. The respondents differed in their knowledge base depending on their specialty, age, and number of years of experience as a physician. The youngest physicians and the least experienced yielded the highest percentage correct. The questions most frequently answered correctly dealt primarily with clinical information about cystic fibrosis, whereas the questions most often answered incorrectly dealt with carrier frequency and testing information. CONCLUSION: The obstetrics-gynecology community is not yet prepared to comply with the NIH Consensus Statement to offer cystic fibrosis carrier screening to couples preconceptionally or prenatally. Further education is necessary before obstetrician-gynecologists can counsel patients adequately.

Adult↗

The NIH criteria for parathyroidectomy in asymptomatic primary hyperparathyroidism: are they too limited?

OBJECTIVE: To determine whether preoperative and postoperative symptoms and outcome differ in patients who meet or fail to meet the NIH criteria for parathyroidectomy. SUMMARY BACKGROUND DATA: The NIH Consensus Conference on primary hyperparathyroidism in 1990 defined criteria for surgical intervention suggesting that some patients can be safely managed without surgery. METHODS: Over a 3-year period, 202 consecutive patients undergoing parathyroidectomy for primary hyperparathyroidism at a tertiary referral center were prospectively given a questionnaire regarding their symptoms and associated conditions during their initial and follow-up office visits as were 63 thyroid control patients. The 178 patients who completed the follow-up questionnaire were assigned to 2 groups according to the NIH criteria for parathyroidectomy. The frequency of preoperative symptoms and conditions associated with primary hyperparathyroidism as well as postoperative improvement in symptoms and surgical outcome were compared. RESULTS: Of the 178 parathyroid patients, 103 met the NIH criteria for parathyroidectomy whereas 75 did not. Patient profiles were similar in each group except mean ages, 55 versus 65, and preoperative serum calcium levels, 11.5 mg/dL versus 11.0 mg/dL (NIH and non-NIH groups, respectively; P < 0.001). The incidence of preoperative nonspecific somatic and neuropsychiatric symptoms and associated conditions was equivalent in both groups and more common than in the 63 thyroid control patients. After parathyroidectomy, symptomatic improvement was dramatic and equal between the 2 parathyroid groups. Postoperative mean serum calcium levels were similar (8.78 mg/dL, NIH group, versus 8.75 mg/dL, non-NIH group). CONCLUSION: Symptoms were more common in patients with primary hyperparathyroidism versus thyroid controls, but were not different between those patients who met the NIH criteria for parathyroidectomy and those who did not. Patients in both parathyroid groups benefited symptomatically after successful parathyroidectomy.

Adult↗

Clinical management of primary hyperparathyroidism and thresholds for surgical referral: a national study examining concordance between practice patterns and consensus panel recommendations.

OBJECTIVE: To determine whether 1990 guidelines established by the National Institutes of Health (NIH) for the optimal management (surgical versus nonsurgical) of patients with asymptomatic primary hyperparathyroidism (PHPT) are known and followed by endocrinologists. METHODS: We surveyed endocrinologists in the United States who were randomly selected in 1998 from two endocrine societies. Endocrinologists were asked about management of asymptomatic patients with PHPT, awareness of NIH recommendations, practice demographics, and annual PHPT case volume. We classified endocrinologists into either low-volume (<12 cases of PHPT per year) or high-volume (> or = 12 cases per year) physicians. RESULTS: Of 374 eligible physicians, 146 (39%) responded to our survey. In comparison with nonrespondents, respondents were of similar age, sex, years in practice, and geographic location profiles; this finding suggested minimal nonresponse bias. More high-volume physicians than low-volume physicians were aware of the NIH guidelines (75% versus 50%; P<0.01). Management of asymptomatic patients was similar between volume groups; overall, 39% of patients were referred for surgical treatment. Nevertheless, considerable variation in management existed; 7% of all physicians referred > or = 90% of their asymptomatic patients for surgical treatment, whereas 31% referred < or = 10%. Adherence to monitoring guidelines for nonsurgically managed patients ranged widely, depending on the specific recommendation (from 6% of physicians obtaining creatinine clearance assessments every 6 months to 78% of physicians ordering serum calcium measurements every 6 months). Surgical referral practices also varied substantially, with 25% of all physicians referring a 40-year-old patient with PHPT when hypercalcemia was mild (< or = 1 mg/dL above normal), 39% when hypercalcemia was moderate, and 31% when hypercalcemia was severe (>1.5 mg/dL above normal). Of the responding physicians, 4% reported that hypercalcemia alone was not sufficient justification to refer a patient for surgical intervention. Higher PHPT case volume was not associated with differences in surgical referral. CONCLUSION: Suboptimal awareness of the 1990 NIH panel recommendations and the substantial variation in clinical management of PHPT indicate that newer NIH guidelines developed in 2002 must be more widely disseminated and strongly recommended if practice patterns are to be influenced and clinical outcomes improved.

Adult↗

What drove changes in the use of breast conserving surgery since the early 1980s? The role of the clinical trial, celebrity action and an NIH consensus statement.

BACKGROUND: Three important events in the history of breast cancer treatment occurred between 1983 and 1995: a large clinical trial, first lady Nancy Reagan's choice of mastectomy and the publishing of an NIH consensus statement. OBJECTIVE: To assess the effects of these events on use of breast conserving surgery (BCS). RESEARCH DESIGN: Data from the cohort study of the surveillance, epidemiology and end results (SEER) Program from 1983 to 1995 were divided into four periods: Baseline, Trial, Celebrity, and Consensus. SUBJECTS: Of the women, 169,466 diagnosed with early stage breast cancer in nine SEER areas. MEASURES: Monthly percentages of BCS. RESULTS: A linear regression model generated a separate intercept and slope term for four time periods, adjusting for demographic characteristics of breast cancer patients. For the Baseline, Celebrity and Consensus Periods, slopes indicated an increasing use of BCS which varied between 0.24% and 0.28% per month. Slopes for these three periods were not statistically different (p = 0.120). In contrast, there was no change in use of BCS during the trial period (p = 0.247). We tested the magnitude of discontinuity between periods. At the beginning of the trial, celebrity and consensus periods, there were increases in BCS of 5.54% (p < 0.001), -3.55% (p < 0.001), and 2.37% (p < 0.001), respectively. CONCLUSIONS: The use of BCS was substantially affected by the reports of a clinical trial of BCS and by celebrity action. These effects were abrupt but transient. The NIH consensus statement stimulated a small change in use of BCS and may be an important intervention for maintaining the increasing trend in use of BCS since the 1990s.

Adult↗

Revision of the Facts on Osteoporosis Quiz.

BACKGROUND: Few instruments exist that measure knowledge of osteoporosis, a health risk for 28 million Americans. The original Facts on Osteoporosis Quiz (FOOQ), which was theoretically informed by Orem's (1995) Self-Care Theory, was published in 1998. In 2000, the National Institutes of Health (NIH) held a consensus conference on osteoporosis in which previous knowledge was modified based on current science. OBJECTIVES: The goal was to update the original instrument based on the latest scientific evidence and to determine its psychometric properties. METHOD: The quiz content was validated by osteoporosis experts and is theoretically informed by Orem's (2001) Self-Care Theory. An iterative process was used to design an instrument with an acceptable reading level. Reliability, item discrimination, and item difficulty were assessed in a convenience sample of 256 participants. RESULTS: The revised quiz, content-based on the 2000 NIH osteoporosis consensus conference, includes 20 questions. The quiz has a content validity index of.87, an internal consistency reliability of.76 and a 6th grade reading level. Item difficulty and item discrimination are also reported. CONCLUSIONS: The revised version of the FOOQ provides a valid, reliable, and theoretically informed instrument with acceptable psychometric properties.

Bias↗