Advisory Panel Recommendations Research Articles

Commentary on the National Mathematics Advisory Panel Recommendations on Assessment

Foundations for Success: The Final Report of the National Mathematics Advisory Panel (2008) recommends that National Assessment of Educational Progress and state tests focus on foundations of algebra and include fewer pattern-type algebra items. Greater mathematics expertise is needed in test development to prevent flawed items. The Panel reached the erroneous conclusion that multiple-choice and constructed response items measure the same thing because it relied on studies where the two item types were constrained to be identical. The Panel’s recommendations on standard setting are misleading because it relied on a single simulation study. By focusing only on special education studies, its discussion of formative assessment implies that formative assessment requires formal tools administered and scored frequently and fails to recognize more interactive forms of feedback found in studies from cognitive science.

Erectile dysfunction as a harbinger for increased cardiometabolic risk

In August 2003, the Minority Health Institute (MHI) convened an Expert Advisory Panel of cardiologists and urologists to design a new practice model algorithm that uses erectile dysfunction (ED) as a clinical tool for early identification of men with systemic vascular disease. The MHI algorithm noted ED as a marker for the presence of cardiovascular disease and suggested that ED may well be a cardiovascular risk equivalent warranting aggressive secondary prevention management strategies, even in the absence of other cardiac or peripheral vascular symptoms. The MHI algorithm stipulates that all men 25 years of age and older should be asked about ED as a routine part of the cardiovascular history during any office visit. The presence of ED should prompt an aggressive assessment for occult vascular disease; many men with erectile difficulty would benefit from early, aggressive management of cardiovascular risk factors with both lifestyle modification and pharmacotherapy to achieve optimal target goals under the existing treatment guidelines. Since publication of the algorithm in 2005, additional research studies have further supported the advisory panel recommendations.

Reducing Hospital-Acquired Heel Ulcer Rates in an Acute Care Facility

A nurse-driven performance improvement project designed to reduce the incidence of hospital-acquired ulcers of the heel in an acute care setting was evaluated. This was a descriptive evaluative study using secondary data analysis. Data were collected in 2004, prior to implementation of the prevention project and compared to results obtained in 2006, after the project was implemented. Data were collected in a 172-bed, not-for-profit inpatient acute care facility in North Central California. All medical-surgical inpatients aged 18 years and older were included in the samples. Data were collected on 113 inpatients prior to implementation of the project in 2004. Data were also collected on a sample of 124 inpatients in 2006. The prevalence and incidence of heel pressure ulcers were obtained through skin surveys prior to implementation of the prevention program and following its implementation. Results from 2004 were compared to data collected in 2006 after introduction of the Braden Scale for Predicting Pressure Sore Risk. Heel pressure ulcers were staged using the National Pressure Ulcer Advisory Panel (NPUAP) staging system and recommendations provided by the Agency for Health Care Quality Research (AHRQ) clinical practice guidelines. The incidence of hospital-acquired heel pressure ulcers in 2004 was 13.5% (4 of 37 patients). After implementation of the program in 2006, the incidence of hospital-acquired heel pressure ulcers was 13.8% (5 of 36 patients). The intervention did not appear to receive adequate staff nurse support needed to make the project successful. Factors that influenced the lack of support may have included: (1) educational method used, (2) lack of organization approved, evidenced-based standardized protocols for prevention and treatment of heel ulcers, and (3) failure of facility management to convey the importance as well as their support for the project.

FDA Panel Recommends Against Depression-Treatment Device

FDA Panel Recommends Against Depression-Treatment Device

FDA Advisory Panel Recommends Muraglitazar for Type 2 Diabetes

FDA Advisory Panel Recommends Muraglitazar for Type 2 Diabetes

Pressure-Related Deep Tissue Injury under Intact Skin and the Current Pressure Ulcer Staging Systems

To identify how current pressure ulcer staging systems and experts describe pressure-related deep tissue injury under intact skin in the published research literature. A systematic review of published English-language literature as of November 2002 with the words decubitus or pressure ulcer(s) in the title. Additional relevant articles were identified by National Pressure Ulcer Advisory Panel members and were included in the analysis. An expert commentary was developed by iterative review by the National Pressure Ulcer Advisory Panel members. Manuscripts were reviewed for staging systems cited or described, definitions of Stage I pressure ulcers, and descriptions or definitions of pressure-related deep tissue injury under intact skin. Ninety-four relevant articles were identified. Seventy-three articles (78%) described a staging system, and 55 of 73 (75%) cited the staging definitions from Shea, the National Pressure Ulcer Advisory Panel, or the Agency for Health Care Policy and Research. The National Pressure Ulcer Advisory Panel's staging definitions were the most frequently cited overall. Twenty-three articles (25%) included some discussion that could be interpreted as relevant to the topic of pressure-related deep tissue injury under intact skin; however, no consistency in definitions of Stage I pressure ulcers or terminology for pressure-related deep tissue injury under intact skin was found. Several pressure ulcer staging systems are frequently cited, but none define pressure-related deep tissue injury under intact skin. The National Pressure Ulcer Advisory Panel recommends using the terms "pressure-related deep tissue injury under intact skin" or "deep tissue injury under intact skin" for describing these lesions and encourages investigators to establish the epidemiology and natural history of these lesions.

EMERGENCY CONTRACEPTION IS NOT ASSOCIATED WITH REDUCTION IN CONTRACEPTIVE USE OR AN INCREASE IN ADVERSE HEALTH OUTCOMES

With the recent FDA advisory panel recommendation that levonorgestrel- only emergency contraception (EC) be given over the counter status clinicians may have many questions about the impact of such a regulatory change on womens health. Levonorgestrel EC when used correctly within 72 hours after unprotected intercourse is 89% effective in reducing the risk of pregnancy following midcycle unprotected sex from an average risk of 8% to 1.1%. However each 12- hour delay in starting EC has been found to reduce efficacy by 50%. Thus prompt access to EC is critical if it is to have the expected effect in reducing unintended pregnancy. The EC regimen has been available over the counter in many other countries and behind-the-counter (via direct dispensation by pharmacists) in five U.S. states. The authors of this study reviewed available literature to assess the likelihood of unintended adverse health outcomes from over-the-counter access to EC. (excerpt)

The Impact of the Media on Women with Breast Implants

Because of the considerable attention given to breast implants by the media, these two surveys were conducted to evaluate how women with breast implants think and feel about the current issues. A telephone questionnaire was administered to 60 women prior to the Food and Drug Administration's moratorium and again following the advisory panel recommendation. The second survey revealed that most subjects felt the media information was accurate, a significant (p = 0.02) change from the first survey responses. The most frequently cited concern about breast implants on the first survey was silicone leakage. It continued to be a major concern on the follow-up survey but was replaced by mammography concerns in the women with augmentation. Concern regarding autoimmune disease increased significantly on the follow-up survey (p = 0.0001). Satisfaction with the decision to have implants changed from 98 percent of the sample before the moratorium to 71 percent of augmentation patients and 79 percent of reconstruction patients after. Women willing to choose the procedure again also declined from 72 percent of reconstructive patients and 58 percent of augmentation patients before to 59 and 52 percent, respectively, after (p = 0.01). The majority (67 percent) acknowledged that the moratorium had an effect on their feelings about breast implants. Negative media information appears to have been a persuasive influence on patients' opinions regarding their implants.

Silicone Breast Implants

To the Editor. —I was disappointed by Marsha F. Goldsmith's article 1 concerning the silicone gel implant controversy. Although her article included information on both sides of the issue, it had several disturbing elements. Goldsmith found a plastic surgeon who won't do an implant unless 'they beg me,' and documented his personal bias against the operation and those surgeons involved in the research and development of a better product. I doubt that his views are shared by most plastic surgeons. Goldsmith quoted the American College of Rheumatology (ACR): The ACR strongly endorses the FDA Advisory Panel's recommendation for further research as well as their ruling to limit silicone gel breast implants for augmentation mammoplasty. Although this sentence did appear in a news release dated March 3,1992, their revised (in April) and most recent release on the issue deleted this statement. Goldsmith did not quote the opinion of the Council on Scientific

The advisory panel recommendations for the dental profession for the 21st century

The advisory panel recommendations for the dental profession for the 21st century

Dow Corning to quit making breast implants

Dow Corning, the largest manufacturer of silicone gel breast implants, disclosed last week that it was quitting the business. In making the announcement, chief executive officer Keith R. McKennon said the company would set up a $10 million fund to carry out research on the implant's safety, and would offer up to $1200 to any woman whose physician recommends implant removal but who cannot afford the surgery. On Jan. 6, Dow Corning and then three other manufacturers voluntarily stopped making these implants after the Food & Drug Administration called for a temporary ban until safety issues could be resolved. In February an FDA advisory panel recommended that availability of silicone implants be sharply limited, and all women receiving them be part of clinical safety studies. FDA Commissioner David A. Kessler has until April 20 to act on the advisory panel's recommendation. After the February advisory panel hearings, Dow Corning officials broadly hinted that the company ...

Projecting future drug expenditures—1992

The effects of inflation, generic competition, and the introduction of new drug entities on future drug expenditures are discussed. The impact of inflation can be predicted by analyzing trends in historical data and determining factors that may affect drug use. Useful sources include U.S. Bureau of Labor Statistics Producer Price Index figures for pharmaceuticals, commercially available data on drug product pricing, and market basket indices compiled by the Health Care Financing Administration (HCFA) and the American Hospital Association. HCFA predicts that quarterly increases in pharmaceutical prices in 1992-93 will range from 6.4% to 8.1%. Pharmaceutical industry analysts predict overall annual inflation rates for pharmaceuticals in 1991-92 ranging from 8% to 10%. To evaluate generic competition, information on the expiration of patents and market exclusivity can be used. Decreases of 30-70% in the list price of a drug product can be expected after the introduction of a generic product, and the price usually stabilizes at approximately 50% of the list price of the innovator product at the time the first generic product was marketed. Predicting when new drug entities will be introduced is difficult; analysts say the usual time from filing of a new drug application to FDA approval is two years. The FDA says approval usually follows within a few weeks after an advisory panel's recommendation for approval, and marketing can be expected within a few months after final FDA approval. Assumptions about future drug expenditures should take into account historical and predicted rates of inflation, the status of generic competition for existing products, and the prospects for introduction of new drug entities.(ABSTRACT TRUNCATED AT 250 WORDS)

Score reporting for the 1991 Medical College Admission Test

In December 1988, a 16-member advisory panel, made up of medical school deans, basic science faculty, clinical scientists, medical education researchers, medical students, premedical advisers, and practicing physicians, completed a full-scale review of the format, content, and score-reporting system of the Medical College Admission Test (MCAT). The advisory panel's recommendations will shape the MCAT to be introduced in 1991. Presented here are data the panel used in deciding to keep the score scale for the upcoming MCAT. Survey data on student selection practices in U.S. and Canadian medical schools and acceptance information for 1987 applicants showed that medical schools used the scores differently within each school and between the schools in deciding whom to admit. The data demonstrated the value of the current reporting system and led the advisory panel to recommend retention of the 15-point MCAT score scale in 1991.

The FDA Advisory Panel's decision on rt-PA.

Considerable dissatisfaction has been expressed over the FDA's Cardio-renal Advisory Panel's recommendation on May 29, 1987 that approval of rt-PA as a thrombolytic agent for the treatment of acute myocardial infarction be delayed. Justification for the Advisory Panel's action appears to be based on a lack of adequate data supporting the clinical benefit and safety of a specific therapeutic regimen of rt-PA, i.e., its molecular form, dosage, and duration of therapy. Although not an issue in the Panel's decision, questions can be raised concerning claims that rt-PA, in comparison to streptokinase, is a safer agent as far as bleeding complications are concerned, and is twice as effective in dissolving coronary thrombi during a period of potential clinical benefit. Also to be considered is the association of its use with a higher incidence of rethrombosis and a much greater cost.