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At least 19 recordsLinked to original sources
PubMed1992

Bioequivalence studies of topical preparations: statistical considerations.

To be approved for marketing, a potential generic pharmaceutical product must demonstrate bioequivalence, that is, a rate and extent of absorption similar to those of the currently marketed ("innovator") product. For oral products, design and statistical analysis for studies conducted to determine whether two products are bioequivalent have become reasonably standardized; the design is crossover, and analysis is based on the two one-sided tests principle. The purpose of this overview is to consider whether the practices for oral products apply to topical products, and where different procedures may be required. The principles behind the practices for oral products are seen, largely, to carry over to topical products.

Administration, Topical↗
PubMedDate not supplied

Selected topics in statistical analysis of clinical research.

Statistical analysis usually is employed in the evaluation of clinical research studies. This paper reviews and makes recommendations in three areas frequently overlooked in the conduct of clinical research: power analysis, specification of a priori research hypotheses, and Bayesian analysis. Power analysis determines the number of subjects required to conduct a meaningful study and should be performed during the planning phase. Research and null hypotheses are essential elements of research design and should be specified prior to statistical analysis. Bayesian analysis can be used both to evaluate diagnostic tests and as an alternative to traditional statistical approaches for testing multiple hypotheses. Application of these methods is described and clinical examples are provided. The discussion is nontechnical and is directed toward the clinical researcher.

Aged↗
PubMed1992

Statistical challenges of AIDS.

"This paper considers questions concerning the incubation period [of HIV infections], the effects of treatments, prediction of AIDS cases, the choice of surrogate end points for the assessment of treatments and design of strategies for screening blood samples. These issues give rise to a broad range of intriguing problems for statisticians. We describe some of these problems, how they have been tackled so far and what remains to be done. The discussion touches on topical statistical methods such as smoothing, bootstrapping, interval censoring and the ill-posed inverse problem, as well as asking fundamental questions for frequentist statistics." The geographical scope is worldwide, with some data for selected developed countries used to illustrate the models.

Acquired Immunodeficiency Syndrome↗
PubMed2006

What do medical schools teach about women's health and gender differences?

PURPOSE: To examine the curricula of U.S. medical schools to assess the inclusion of women's health and gender-specific information and identify institutional characteristics associated with this content. METHOD: Using data from the Association of American Medical Colleges' Curriculum Management and Information Tool (CurrMIT), in November 2003 to February 2004 the authors performed a curriculum search of schools that entered course/clerkships in CurrMIT to identify interdisciplinary women's health or gender-specific courses/clerkships. A subset of schools that entered comprehensive information in CurrMIT was searched for a specified list of women's health topics and or gender-specific content on any topic. Statistical analyses were performed to assess the relationship between frequency of topics and school characteristics. RESULTS: The authors identified 95 schools that entered related courses/clerkships. Ten courses/clerkships at nine schools met criteria for an interdisciplinary women's health course/clerkship. In the subset of 60 schools with comprehensive CurrMIT information, 18 specified women's health topics were identified, as well as 24 topics on gender-specific content, for a total of 42 topics. The number of topics taught ranged from zero to 26 (mean = 11). More than 50% of these schools taught 11 of the 18 specified topics, while fewer than 30% included gender-specific topics. There was no association in bivariate analysis between the mean number of topics taught and schools' characteristics; however, a women's health program (p= .01) and female dean (p= .06) were positively associated in a regression model. CONCLUSIONS: Few schools offer interdisciplinary women's health courses/clerkships or include gender-specific information in their curricula. A designated women's health program may increase this content in schools' curricula.

Clinical Clerkship↗
PubMed2002

Some statistical aspects of food intake assessment.

OBJECTIVE: To present the results of the statistical working group of the EFCOSUM project on estimating the minimum sample size for a pan-European dietary survey. BACKGROUND AND METHODS: Numerous statistical issues are involved when planning a nutritional survey aimed at evaluating various indicators, especially if it will be carried out in different countries. The plenary workshop of the EFCOSUM project has chosen four relevant statistical topics: the sample size estimation for dietary surveys, the number of repeated measurements needed to estimate usual intake for each individual; the statistical presentation of data; and the statistical procedures for estimating the usual intake distribution from a limited number of days of observation. This article deals with the first three topics mentioned. The participants of the EFCOSUM project answered a small questionnaire in order to get agreement on the method of estimating a minimum sample size in the context of a monitoring of dietary indicators. Data on the variability of dietary indicators of interest was also collected, in order to calculate a minimum sample size. RESULTS AND CONCLUSION: The main result was that a minimum sample size of 2000 adults in each European country will be needed in order to identify trends in the mean intake of the most relevant foods and nutrients in Europe. This sample size should be higher if trends have to be indentified for socio-demographic subgroups.

Data Interpretation, Statistical↗
PubMed2002

The ethics of consulting for the tobacco industry.

This article describes how and why I became involved in consulting for the tobacco industry. I briefly discuss the four relatively distinct statistical topics that were the primary focus of my work, all of which have been central to my published academic research for over three decades: missing data; causal inference; adjustment for covariates in observational studies; and meta-analysis. To me, it is entirely appropriate to present the application of this academic work in a legal setting.

Consultants↗
PubMed1994

1991 Census of Great Britain: summary of results.

All the scheduled Topic Statistics Population Statistics reports from the 1991 Census are now published. This article illustrates the Census range of statistics contained in these reports, making some comparisons with results from the 1981 Census for those topics where there are comparable figures.

Adolescent↗
PubMed1987

Review: clinical trials in peptic ulcer disease--problems of methodology and interpretation.

This review focuses on the methodology and interpretation of drug trials in peptic ulcer disease. The problems of planning and conduct that are discussed include the ethics of using placebo, eligibility criteria, estimations of sample size, stopping rules, randomization, blinding, and efficacy criteria, that is, ulcer healing and pain relief in the short term and prevention of relapse and complications in the long term. Statistical topics covered include confidence intervals, evaluation of survival type data, post-stratification, and sub-group analysis. The difference between clinical and statistical significance is discussed, major problems being overemphasis on P-value, type II errors, and post hoc power determinations. Explanatory and pragmatic questions are based on compliance-to-protocol and intention-to-treat cohorts, respectively, and involve problems of compliance testing, evaluation of withdrawals, and the use of fixed-dose regimens. The rather slow process for clinical trials to gain acceptance is described, and it is proposed to rely on disease-related and behavioural barriers, lack of knowledge of the inherent limitations of methodology, and overemphasis on the subject of peptic ulcer healing, in addition to some concern at the relevance of assessing long-term drug intervention by repeated endoscopies rather than by studying symptoms and the incidence of complications. We foresee an increased impact of clinical trials on ulcer research and therapeutic decision making, provided physicians are able to develop the proper methodology to answer the relevant questions.

Anti-Ulcer Agents↗
PubMed2002

Statistical issues in assessing powered toothbrushes.

A symposium on powered toothbrushes was held at the 2000 IADR General Session. The author was asked to address statistical issues in conducting clinical studies. The objective was to cover important statistical topics that should be considered in scientific investigations, including designing the study, analyzing the results, and performing a critical scientific review. The American Dental Association (ADA) established guidelines during the 1990s. The author discusses these guidelines and addresses statistical issues they do not cover.

American Dental Association↗
PubMed1981

Quantification of protease, amylase and lipase in the gut of Schizodactylus monstrosus during the postembryonic developmental stage. Effect of starvation, stress and topical application of juvenile hormone analogue.

A quantitative picture is presented on the activities and distribution of three major digestive enzymes in the postembryonic and adult stages of Schizodactylus monstrosus. The activity of enzymes in adult insects of both sexes has also been studied under starvation stress and after the topical application of juvenile hormone analogue. Results show that amylase activity was much higher in the early stages of development while in later stages protease and lipase activity was more significant. Protease activity was highest in the adult male, while the activity of all the enzymes reached its maximum in pregnant females. Starvation stress in adult individuals led to a slight decline of enzyme activity which was insignificant statistically. Topical application of JHa in high doses caused a steady increase in the activity of all the enzymes of which the increase of protease was statistically significant. The probable reasons for the quantitative variation have been discussed.

Administration, Topical↗
PubMed2006

The content of medical journal Instructions for authors.

STUDY OBJECTIVE: We describe the general and statistical content of the Instructions for Authors of major medical journals. METHODS: This article reports on 2 observational studies. In study 1, we investigated the online versions of Instructions for Authors of 166 journals from 33 specialties for the presence of content about 15 methodologic and statistical topics. In study 2, we categorized the general content of the online versions of the Instructions for Authors of 35 medical journals. Two abstractors independently assigned the content into 18 categories and counted the total number of words devoted to each category. Interrater reliability of the classification was assessed. RESULTS: Less than half of the 166 Instructions for Authors in study 1 provided any guidance on statistical methods, and the majority failed to cite accepted publication standards such as the International Committee of Medical Journal Editors Uniform Guidelines or CONSORT. Only 13% of journals commented on the content and style of data tables and figures. The 35 Instructions for Authors in study 2 varied greatly in length (mean 3,308; median 2,283; range 885 to 18,927) and, with few exceptions, focused on formatting issues. Forty-three percent of Instructions offered no advice on scientific content, and only 5 journals devoted more than 10% of their words to scientific content. CONCLUSION: There is great heterogeneity among medical journal Instructions for Authors. Instructions provide little guidance about methodologic and statistical issues, and the advice provided is often contradictory among journals.

Guidelines as Topic↗
PubMed1993

The selection of appropriate health education topics for publication in the press.

OBJECTIVE: To compare the perceptions of patients, doctors, and journalists concerning the priority of health education topics in the media. DESIGN: A cross sectional Knowledge, Attitude, and Practice (K.A.P.) study. A self-administered questionnaire was used during 2 weeks in September 1990; it included questions on sociodemographic characteristics and on each group's perceived opinion of priority health topics for discussion in the media. SETTING: Two university hospitals and six newspapers offices in Riyadh Saudi Arabia. PARTICIPANTS: 300 randomly selected outpatients aged 12 years and over, and 77 doctors. 31 journalists from six local newspapers also participated. MAIN OUTCOME MEASURE: The ratio of respondents in the three study groups who believed there was a need for health education in 22 topics. RESULTS: For most of these topics, statistically significant differences were found between the perceptions of the three groups. Doctors put more emphasis on preventive issues, while patients perceived new therapeutic and diagnostic methods as important more commonly than the other two groups. CONCLUSION: A team consisting of doctors, journalists, and patients should be formed to select health education topics in the media. Priority should be given to topic preferences shared by both doctors and the public.

Adolescent↗
PubMed1993

Vasectomy and prostate cancer risk: methodological review of the evidence.

Two recent studies have reported a significantly elevated risk of prostate cancer among vasectomized men. To assess whether the new results conflict with earlier studies that found no significant overall association, and, if so, whether such a conflict could have a methodological basis, we reviewed the six major epidemiological studies of this topic. Statistical analysis revealed significant (p < 0.01) heterogeneity among the associations in the six studies, attributable to one of the recent studies. Scrutiny of the studies for fulfillment of eight methodological standards for scientific validity revealed that no study completely fulfilled more than four standards, and that all studies were deficient in avoiding detection bias and obtaining accurate vasectomy histories. Our review indicates that the evidence on this topic is indeed conflicting, that the quality of the evidence does not resolve the conflict, and that future studies of this topic, designed to ensure scientific credibility of results, are needed.

Adult↗
PubMed2006

Integrating CAM into nursing curricula: CAM camp as an educational intervention.

BACKGROUND: In 2002, the University of Washington School of Nursing (SON) partnered with Bastyr University on a five-year plan to offer a four-week intensive "CAM Camp" (CAMp) for SON faculty members and medical students from across the country. The four-week educational program introduced attendees to various complementary and alternative medicine (CAM) modalities through didactic and experiential learning. OBJECTIVE: To enhance complementary and alternative medicine content in a SON curriculum and to increase SON faculty knowledge and understanding about (1) the range of CAM therapies, (2) the theoretic and cultural backgrounds of these therapies, and (3) their potential contributions to the health of diverse populations. DESIGN: A descriptive pretest, posttest design was used to compare pre-CAMp CAM knowledge and CAM course content with post-CAMp knowledge levels of faculty and course CAM content. RESULTS: On post-CAMp surveys, familiarity with CAM modalities was rated with mixed results as compared with positive reports on the qualitative interviews. Interview results were more positive about CAM in general and were less specific about individual CAM topics. Statistically significant increases in competences were evident in each of 13 competencies rated with four competencies at P < .01. The number of required and elective courses containing CAM content increased as did the CAM content in continuing education conferences offered by the SON.

Clinical Competence↗