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Biomedical subjects

K J Vener

Publications and source records attributed to K J Vener.

10 recordsLinked to original sources
PubMed1993

A statistical model validating triage for the peer review process: keeping the competitive applications in the review pipeline.

Triage of grant application at the National Institutes of Health (NIH) is a process whereby an initial screening of applications by a scientific peer review group eliminates applications that are not competitive for awards. The process of application triage has been limited to those applications submitted to the NIH in response to an RFA (Request for Applications). A hypergeometric model was developed to determine the extent to which five, six, seven, or eight member triage teams or subsets of 12-to-20 member full committees could provide a statistically defensible triage decision. Although the intent of triage is to remove from review those applications that are noncompetitive, the model was weighted in favor of the applicant to minimize the likelihood that highly competitive applications would be eliminated. Within the assumptions and rules developed, it was determined that there was little likelihood that the latter would occur. For example, in the worst case scenario, the greatest probability that a highly competitive application would be knocked out of competition is P < or = 0.014 in the case of a five-member triage subset of a 20-member committee. Using the latter case, the model was tested on a set of 73 applications that were submitted to the National Cancer Institute for action at the February 1993 National Cancer Advisory Board. The model selected for triage required that each application be assigned to five reviewers, that each reviewer be blinded to the review assignments of the other reviewers, and that four noncompetitive votes be registered to triage out an application. Each of 19 applications received four to five noncompetitive votes, and were triaged out of the review process. The remaining 54 applications were then reviewed according to the usual NIH review process. Four of the applications received three noncompetitive triage votes each and were either rated as not recommended for further consideration (NRF, n = 2)) or received priority scores > or = 250 (n = 2) (The smaller the priority score the better the technical merit). Thirteen of the 53 applications received two noncompetitive votes. Of the latter, two were not recommended for further consideration and the remaining 11 received priority scores between in excess of 200. The distribution of competitive applications was such that funding was limited to those applications with priority scores of less than 190. Thus, the data suggest that the conservative model is valid such that the likelihood of eliminating a highly competitive application from consideration for funding is remotely small.(ABSTRACT TRUNCATED AT 400 WORDS)

Competitive Bidding↗
PubMed1992

Timed treatment of the arthritic diseases: a review and hypothesis.

Evidence has been accumulating regarding the importance of biological rhythms in the diagnosis and treatment of a variety of diseases and disorders. Increasingly, the arthritides have shown statistically quantifiable rhythmic parameters. Included in the latter group are joint pain and joint size. In addition, a number of drugs used to treat rheumatic diseases have varying therapeutic and toxic effects based on the time of day of administration. Among these drug classes are nonsteroidal antiinflammatory drugs, glucocorticoids, and a number of cytostatic agents. In the last group of agents, experience in treating malignant disease suggests that time-specified treatment may reduce the toxic effects of low-dose cytostatic treatment of rheumatoid arthritis (RA) and related diseases. This article reviews that evidence and suggests a rationale for the timed treatment of RA with methotrexate.

Animals↗
PubMed1991

Analysis of SBIR phase I and phase II review results at the National Institutes of Health.

A cohort of phase I and phase II summary statements for the SBIR grant applications was evaluated to determine the strengths and weaknesses in approved and disapproved applications. An analysis of outcome variables (disapproval or unfunded status) was examined with respect to exposure variables (strengths or shortcomings). Logistic regression models were developed for comparisons to measure the predictive value of shortcomings and strengths to the outcomes. Disapproved phase I results were compared with an earlier 1985 study. Although the magnitude of the frequencies of shortcomings was greater in the present study, the relative rankings within shortcoming class were more alike than different. Also, the frequencies of shortcomings were, with one exception, not significantly different in the two studies. Differences in the summary statement review may have accounted for some differences observed between the 1985 data and results of the present study. Comparisons of Approved/Disapproved and Approved-Unfunded/Funded yielded the following observations. For phase I applicants, a lack of a clearly stated, testable hypothesis, a poorly qualified or described investigative team, and inadequate methodological approaches contributed significantly (in that order) to a rating of disapproval. A critical flaw for phase II proposals was failure to accomplish objectives of the phase I study. Methodological issues also dominate the distinctions in both comparison groups. A clear result of the data presented here and that published previously is that SBIR applicants need continuing assistance to improve the chances of their success. These results should serve as a guide to assist NIH staff as they provide information to prospective applicants focusing on key elements of the application. A continuing review of the SBIR program would be helpful to evaluate the quality of the submitted science.

Commerce↗
PubMed1990

The circadian rhythm of biliary colic.

We evaluated 50 consecutive patients with symptomatic gallstones for the clinical features of biliary pain with particular reference to the timing of their painful episodes. Thirty-eight of the 50 patients were able to provide the time of onset of biliary pain in the 24-h cycle. The time of onset of biliary pain displays significant circadian periodicity (p = 0.0032), with its peak at 00:25 h. Forty-five patients had more than 1 episode of pain. Of these 84% had either all or over half of their attacks of biliary pain at the same clock time. Twenty-two patients with renal colic (a close parallel to biliary pain) and 31 patients with episodic abdominal pain from miscellaneous causes showed no circadian or other periodicity in the time of onset of pain. In only 1 of these patients did the abdominal pain recur consistently at the same clock time. "Typical" biliary pain has its onset at night and tends to recur at the same clock time. It is steady and relatively mild, lasting 1-5 h, it is felt in the right upper quadrant or the epigastrium, may radiate to a variety of sites, is associated with some additional symptoms, and is not usually related to meals. The chronobiological and other features of biliary pain reported here should be useful in the diagnostic evaluation of abdominal pain.

Adolescent↗
PubMed1987

Temporal aspects of the pathophysiology of human ulcer disease.

In this paper, a peptic ulcer is considered from the perspective that it is representative of a heterogeneous group of multifactorial determined or influenced disorders having a common pathomorphologic expression. This heterogeneity involves pathophysiological attributes, including both functional (including secretory and motility events and their respective driving mechanisms) and morphologic alterations that relate to mucosal resistance. Patients with duodenal ulcer (DU) have been observed to exhibit alterations, in comparison to normal subjects, in the circadian rhythm characteristics of several gastrointestinal functions. Prominent among these are altered amplitudes of several circadian-organized gastric variables, such as intragastric pH, gastrin, pepsinogen and gastric mitotic index. With respect to any given variable, a reduced group amplitude (a measure of one-half the peak-trough difference of a 24-hr rhythm) could signify an increased dispersion of acrophases (the location of the peak of a circadian rhythm along the 24-hr time scale) reflecting interindividual variation in synchronization schedules, sleep-wake patterns, or chronobiologic alterations. A reduced interindividual amplitude further supports the concept of the heterogeneity of peptic disease. A decrease in the intraindividual amplitude of certain gastric rhythms implies an altered temporal pattern over the 24 hr. This is consistent with the hypothesis of a decrease in the amount of time available for recovery of a given function or set of integrated functions, and hence, increased susceptibility to mucosal injury. Normal high-amplitude variation in gastrointestinal functioning over the 24 hr appears to be required for natural restoration of the gut.

Circadian Rhythm↗
PubMed1985

National Institutes of Health phase I, Small Business Innovation Research applications: fiscal year 1983 results.

A review of the 356 disapproved Small Business Innovation Research (SBIR) proposals submitted to the National Institutes of Health (NIH) for fiscal year 1983 funding was undertaken to identify the most common shortcomings of those disapproved applications. The shortcomings were divided into four general classes by using the scheme developed by other authors when describing the reasons for the disapproval of regular NIH research applications. Comparison of the reasons for disapproval of SBIR applications with regular applications suggests comparable difficulties in the areas of the problem and the approach. There is some indication, however, that the SBIR proposals may have been weaker in the category of the principal investigator (PI). In general, it is the responsibility of the PI to demonstrate that the work is timely and can be performed with available technology and expertise, and that the guidelines for the NIH SBIR program have been satisfied.

Commerce↗
PubMedDate not supplied

The effect of shift work on gastrointestinal (GI) function: a review.

Recent statistics suggest approximately 20 percent of the American work force is engaged in shift work. The evidence which is reviewed in this manuscript suggests that shiftworkers are at risk for the development of gastrointestinal diseases or disorders. The susceptibility to shiftwork related gastrointestinal complaints may be related to the disruption of the individual's time structure. Central nervous system and endocrine mechanisms which may contribute to the pathogenesis of digestive diseases/disorders in shift workers are discussed.

Adult↗