Usability of advanced pneumatic compression to treat cancer-related head and neck lymphedema: A feasibility study.

BACKGROUND: This functional usability study assessed ease of use, fit, comfort, and potential clinical benefits of advanced pneumatic compression treatment of cancer-related head and neck lymphedema. METHODS: Patient-reported comfort and other treatment aspects were evaluated and multiple face and neck measurements were obtained on 44 patients with head and neck lymphedema before and after 1 treatment session to assess usability and treatment-related lymphedema changes. RESULTS: A majority of the patients (82%) reported the treatment was comfortable; most patients (61%) reported feeling better after treatment, and 93% reported that they would be likely to use this therapy at home. One treatment produced overall small but highly statistically significant reductions in composite metrics (mean ± SD) of the face (82.5 ± 4.3 cm vs 80.9 ± 4.1 cm; P < .001) and neck (120.4 ± 12.2 cm vs 119.2 ± 12.1 cm; P < .001) with no adverse events. CONCLUSION: Results found the treatment to be safe, easy to use, and well tolerated while demonstrating edema reduction after a single initial treatment.

Determinants of success in endoscopic cerebrospinal fluid leak repair.

OBJECTIVES: To identify factors influencing success in endoscopic repair of CSF leaks of the anterior skull base. METHODS: Through retrospective chart review, 24 endoscopic closures of anterior skull base CSF leaks were analyzed for factors correlating with initial repair outcome. RESULTS: Thirteen patients with either spontaneous leaks or iatrogenic leaks arising from FESS were repaired with significantly lower recurrence rate (8%) than 11 patients with leaks induced by skull base procedures (45%). However, in the latter group, only 14% recurred when the dural defect was directly visualized, whereas leaks always recurred when bony dehiscences were patched in the absence of visible dural defects. Such defects were least frequently localized in patients with craniotomy-induced leaks. A trend toward morbid obesity was also noted among repair failures. CONCLUSIONS: Direct visualization of the dural defect is essential for endoscopic repair of anterior skull base CSF leaks, with craniotomy-induced leaks being the most challenging to localize. Obesity is another likely factor contributing to repair failure.

Tutorials in clinical research: VII. Understanding comparative statistics (contrast)--part B: application of T-test, Mann-Whitney U, and chi-square.

OBJECTIVE: This tutorial on comparative statistics has been written in two complementary segments. The first paper (part A) focused on explaining the general concepts of the null hypothesis and statistical significance. This second article (part B) addresses the application of three specific statistical tests. These two articles should be read sequentially and the first article should be available for reference while one reads the second. STUDY DESIGN: Tutorial. METHODS: The authors met weekly for 10 months to discuss clinical research articles and the applied statistics. The difficulty was not the material but the effort to make it easy to read and as short as possible. RESULTS: The article discusses the application of three common statistical indexes of contrast, chi2, Mann-Whitney U, and Student t-test and other concepts, such as sample size, degrees of freedom, errors, power, and confidence intervals. CONCLUSIONS: Statistical tests generate a number known as a statistic (chi2, U, t), which is sometimes called a "critical ratio" because it helps us to make a decision. This number is then associated with a probability, or P value. Sample size is a crucial element in the initial design of a research project and in the subsequent ability of the results to show statistical significance if the difference is clinically important. The example data used in this paper demonstrate the application of the three specific tests and illustrate the effect of sample size on the results.

Tutorials in clinical research: part VII. Understanding comparative statistics (contrast)--part A: general concepts of statistical significance.

OBJECTIVES/HYPOTHESIS: The present tutorial is the seventh in a series of Tutorials in Clinical Research. The specific purpose of the tutorial (Part A) and its sequel (Part B) is to introduce and explain three commonly used statistical tools for assessing contrast in the comparison between two groups. STUDY DESIGN: Tutorial. METHODS: The authors met weekly for 10 months discussing clinical research studies and the applied statistics. The difficulty was not in the material but in the effort to make the report easy to read and as short as possible. RESULTS: The tutorial is organized into two parts. Part A, which is the present report, focuses on the fundamental concepts of the null hypothesis and comparative statistical significance. The sequel, Part B, discusses the application of three common statistical indexes of contrast, the chi2, Mann-Whitney U, and Student t tests. CONCLUSIONS: Assessing the validity of medical studies requires a working knowledge of research design and statistics; obtaining this knowledge need not be beyond the ability of the busy surgeon. The authors have tried to construct an accurate, easy-to-read, easy-to-apply, basic introduction to comparing two groups. The long-term goal of the present tutorial and others in the series is to facilitate basic understanding of clinical research, thereby stimulating reading of some of the numerous well-written research design and statistical texts. This knowledge may then be applied to the continuing educational review of the literature and the systematic prospective analysis of individual practices.

Tutorials in clinical research, part VIII: Creating a journal club.

OBJECTIVE: The present report is the eighth in a series of sequential tutorials entitled "Tutorials in Clinical Research." The objective of the report is to provide the reader with information to create or refine a journal club. STUDY DESIGN: Tutorial. METHODS: The authors met weekly for 3 months and discussed the features of a journal club that would be of interest to otolaryngologists. A Medline search provided a number of relevant articles for review. RESULTS: The report is organized into the following sections: Introduction, History of Journal Club, Goals of Journal Club, Basic Organization, Factors Associated With Successful Journal Clubs, Design of Journal Club, Selecting Literature, Evaluation of Journal Club, and Summary. CONCLUSIONS: There is a paucity of information within the otolaryngology literature regarding the journal club and the significant role it can play in physician education. The flexible nature of the journal club gives it the potential to address many educational needs. Its relevance has never been greater.

Tutorials in clinical research, part VI: descriptive statistics.

OBJECTIVES: This is the sixth in a series of Tutorials in Clinical Research. The objectives of this tutorial are to produce a brief, step-by-step, user-friendly atlas with clinical scenarios and illustrative examples to serve as ready references and, it is hoped, to open an inviting door to understanding statistics. STUDY DESIGN: Tutorial. METHODS: The authors met weekly for 6 months discussing clinical research articles and the applied statistics. Liberal use of reference texts and discussion focused on constructing a tutorial that is factual as well as easy to read and understand. RESULTS: The tutorial is organized into five sections: Overview, Key to Descriptive Summaries, Steps in Summarizing Descriptive Data, Understanding the Summaries of Specific Data Types, and Understanding Scope or Dispersion of Data. CONCLUSIONS: Assessing the validity of medical studies requires a working knowledge of statistics; however, obtaining this knowledge need not be beyond the ability of the busy surgeon. Desire is the only limiting factor. We have tried to construct an accurate, basic, easy-to-read-and-apply introduction to the task of summarizing the characteristics of a single variable. This is known as descriptive statistics.

Tutorials in clinical research: part V: outcomes research.

OBJECTIVES: This is the fifth in a series of sequential "Tutorials in Clinical Research." The objective of the present report is to give the reader a broad overview of the field of outcomes research. This summary is intended to enable the reader to understand outcomes research methodology and to start the design of an outcomes research study. STUDY DESIGN: Tutorial. METHODS: The authors developed the report from available materials and refined it to be concise but complete for use by the practicing clinician. RESULTS: We describe the basic steps of record-based and patient-based outcomes research, including development of a staging system, identification of comorbid conditions, and creation or identification of an outcomes instrument. CONCLUSION: Outcomes research is a unique methodology that uses patient-based outcomes to assess the effectiveness of medical treatment.

Tutorials in clinical research: part IV: recognizing and controlling bias.

OBJECTIVE: This is the fourth of a series of Tutorials in Clinical Research (1-3). The objectives of this article are to heighten reader awareness of biases and of methods to reduce their impact and to provide an easy reference document for the reader during future journal reading. STUDY DESIGN: Tutorial. METHODS: The authors met weekly for 4 months discussing clinical research articles and biases for which they might be at risk. Liberal use of reference texts and specific articles on bias were reviewed. Like the example by Sackett, biases were catalogued to create an easily understood reference. Articles were chosen to demonstrate how understanding bias might facilitate assessment of the validity of medical publications. RESULTS: The article is organized into three main sections. The first section introduces specific biases. Two tables serve as rapid reference tools. The second section describes the most common biases linked to specific research approaches and reviews techniques to minimize them. The last section demonstrates the application of the information to an article in a manner that can be applied to any article. CONCLUSIONS: Assessing the validity of a medical publication requires an awareness of bias for which the research is inherently at risk. A review of the publication to determine what steps the authors did or did not undertake to minimize the impact of biases on their results and conclusions helps establish the validity. This article should be of assistance in this critical review task.