The P Value Problem in Otolaryngology: Shifting to Effect Sizes and Confidence Intervals.

There is a lack of reporting effect sizes and confidence intervals in the current biomedical literature. The objective of this article is to present a discussion of the recent paradigm shift encouraging the use of reporting effect sizes and confidence intervals. Although P values help to inform us about whether an effect exists due to chance, effect sizes inform us about the magnitude of the effect (clinical significance), and confidence intervals inform us about the range of plausible estimates for the general population mean (precision). Reporting effect sizes and confidence intervals is a necessary addition to the biomedical literature, and these concepts are reviewed in this article.

Practical guide to understanding clinical research compliance.

Noncompliance with federal regulations, as monitored through institutional review boards for the ethical conduct of clinical research, can occur, even to seasoned investigators. The cause of this noncompliance can be that an investigator is overloaded, does not know the regulations, or does not take the time to pay attention to the details. Sometimes it happens just because of inevitable human error that can befall us all at any time. The authors begin by citing the inherent differences between clinical practice and clinical research. This is followed by an illustration of common noncompliance errors, with examples, followed by general and specific concepts and methods to minimize noncompliance events. The objective of this article is to condense the myriad details involved in conducting clinical research into a set of manageable recommendations that can be recalled easily before and during the research. The material supporting these recommendations comes from years of institutional review board work at several institutions and consultation with experienced principal investigators and their research coordinators.

Practical guide to understanding Comparative Effectiveness Research (CER).

"Comparative effectiveness research" (CER) is not a new concept; however, recently it has been popularized as a method to develop scientifically sound actionable data by which patients, physicians, payers, and policymakers may make informed health care decisions. Fundamental to CER is that the comparative data are derived from large diverse populations of patients assembled from point-of-care general primary care practices and that measured outcomes include patient value judgments. The challenge is to obtain scientifically valid data to be acted upon by decision-making stakeholders with potentially quite diversely different agenda. The process requires very thoughtful research designs modulated by complex statistical and analytic methods. This article is composed of a guiding narrative with an extensive set of tables outlining many of the details required in performing and understanding CER. It ends with short discussions of three example papers, limitations of the method, and how a practicing physician may view such reports.

Practical guide to understanding the need for clinical practice guidelines.

With recent changes in the landscape of health care, clinical practice guidelines (CPGs) have proliferated. Attitudes about guidelines differ considerably, forming 2 competing viewpoints with considerable tension between them. Some feel CPGs are unneeded or are efforts to create automated "cookie cutter" medical practice; at best, they are perceived as suggestions that may be altered by experience. Others feel they are mandates that must be followed to the letter. This article attempts to explain how and why we have arrived at this point and to explain the origins of the differing viewpoints. We begin by describing the 2 viewpoints and proceed to define the origin of medicine as a profession and to chronicle the evolution of health insurance, medical education, and scientific methods for evaluating evidence.

Practical guide to understanding multivariable analyses: Part A.

Multivariable analyses are complex statistical methods to evaluate the impact of multiple variables on outcomes of interest. Books have been written on each of these methods detailing the mathematical and statistical objectives and processes. However, we have found very little in the way of brief reports that help the nonstatistically trained physician obtain a basic understanding of multivariable analyses in order to have some understanding of the increasing literature using these methods. This work is organized in 2 parts. This article, Part A, addresses the "big 4" algebraic methods of multivariable analysis. The primary focus of Part A is to present a brief "primer" to help the reader understand the methods and uses; it expressly avoids the many details of statistical assumptions, calculations, and myriad branching alternatives. Part B will concentrate on conjunctive consolidation and will focus on enough information to allow the interested reader to actually perform the analysis. For the statistical scholar, we have included references to several voluminous serious works.

Practical guide to understanding multivariable analyses, Part B: conjunctive consolidation.

Conjunctive consolidation, one method of multivariable analysis by arranging data into clusters, is intuitive and transparent. An unexpected consequence in writing this article was the discovery of just how useful it is in critically analyzing articles and in designing new projects. It has stimulated a fresh understanding as to the value of multivariable thinking in all clinical research. This article is organized into the sequential steps for performing conjunctive consolidation for critically analyzing an article of interest and for completing the process, pending all required data are available. Investigators, particularly those who perform clinical research, should consider conjunctive consolidation as a valuable method of multivariable analysis with which to report data.

Sudden sensorineural hearing loss and delayed complete sudden spontaneous recovery.

This is a case report of a 53-yr-old female who experienced sudden sensorineural hearing loss (SSNHL) accompanied by roaring tinnitus in her right ear. The patient's hearing partially improved in the low frequencies in response to intratympanic injections. Given that her hearing loss did not improve further, the patient was fitted with a hearing aid to mask the tinnitus and restore a sense of balance between the two ears. Approximately 9 mo postonset of the SSNHL, a complete spontaneous recovery of hearing occurred. Such a delayed and complete recovery is highly unusual. This case highlights that the spontaneous recovery in hearing indicates that the pathological cause for the SSNHL involved a process that was capable of repair or regeneration, thus ruling out pathologies related to cochlear hair cell destruction or nerve fiber loss. This leaves a possibility that the event causing the onset of the SSNHL resulted in a disruption of the ion homeostatic properties of the cochlea via the production of the endocochlear potential.

Auditory brainstem response testing in neurodiagnosis: structure versus function.

This case report describes a 44-yr-old female referred by an outside facility who presented with progressive hearing loss in her left ear. Magnetic resonance imaging (MRI) results were normal, but a battery of audiological tests suggested neural hearing loss in the left ear. Following diagnosis of left neural hearing loss, the patient was successfully fit with a hearing aid on the left ear. This case report underlines the importance of using a battery of medical, radiologic, and audiological tests in the accurate determination of hearing loss site of lesion. Obvious retrocochlear dysfunction was revealed via auditory brainstem response (ABR) testing. MRI did not reveal underlying structural abnormality. Without the addition of the ABR to the diagnostic test battery, a cochlear hearing loss site of lesion would most likely have been diagnosed. Accurate diagnosis of hearing loss site of lesion is critical for patient counseling and treatment as well as for patient follow-up and monitoring.

Practical guide to choosing an appropriate data display.

The primary objective of graphing research data is to communicate key information visually in a rapid, accurate, and concise way. Graphs might be considered visual take-home lessons of the major point(s) of the manuscript. In choosing a graph, it is tempting to concentrate only on ways of illustrating summary statements characterizing the group(s). However, individual patients are unique, and their characteristics or outcomes may not be predicted by a group summary. Consequently, if possible, graphs should demonstrate individual responses as well as group summaries. "Graphical literacy," "graphical excellence," and "graphical acumen" are achievable with work and collaboration. To produce a well-designed graph, a combination of by-subject detail and overall results should be the goal within the same illustration. The practice gap addressed in this article is that little attention from authors, reviewers, editors, and publishers seems to be paid to graphical literacy. The purpose of this article is to present some practical guidelines for choosing or evaluating more appropriate data displays.

Hyperventilation-induced nystagmus and vertigo after stereotactic radiotherapy for vestibular schwannoma.

OBJECTIVE: To describe the phenomenon of hyperventilation-induced nystagmus (HVN) after stereotactic radiotherapy for vestibular schwannoma. PATIENTS: We present 2 patients with vestibular schwannoma and no pretreatment vestibular symptoms who both received stereotactic radiotherapy. Within 2 months of completing treatment, both patients developed intense vertigo while exerting themselves. Video-oculography demonstrated an intense nystagmus with the fast phase directed toward the side of the schwannoma in both patients. INTERVENTION: Diagnostic. RESULTS: Patients who have undergone surgical resection of their vestibular schwannoma, or have a large tumor, will often demonstrate HVN with the fast phase directed away from the side of the tumor. This is distinct from patients with smaller lesions who have a fast-phase nystagmus toward the tumor's side. This second type of nystagmus is thought to originate from changes in the extracellular calcium concentration secondary to hyperventilation-induced alkalosis. CONCLUSION: We hypothesize that stereotactic radiotherapy induced greater demyelination of the vestibular nerve leading to the observable sign of HVN. These patients represent the first reported cases of HVN after stereotactic radiation and illustrate the pathophysiology of HVN, which may lead to a greater understanding of the effects of stereotactic radiotherapy.

A practical guide to surveys and questionnaires.

Surveys with questionnaires play a vital role in decision and policy making in society. Within medicine, including otolaryngology, surveys with questionnaires may be the only method for gathering data on rare or unusual events. In addition, questionnaires can be developed and validated to be used as outcome measures in clinical trials and other clinical research architecture. Consequently, it is fundamentally important that such tools be properly developed and validated. Just asking questions that have not gone through rigorous design and development may be misleading and unfair at best; at worst, they can result in under- or overtreatment and unnecessary expense. Furthermore, it is important that consumers of the data produced by these instruments understand the principles of questionnaire design to interpret results in an optimal and meaningful way. This article presents a practical guide for understanding the methodologies of survey and questionnaire design, including the concepts of validity and reliability, how surveys are administered and implemented, and, finally, biases and pitfalls of surveys.

A practical guide to understanding Kaplan-Meier curves.

In 1958, Edward L. Kaplan and Paul Meier collaborated to publish a seminal paper on how to deal with incomplete observations. Subsequently, the Kaplan-Meier curves and estimates of survival data have become a familiar way of dealing with differing survival times (times-to-event), especially when not all the subjects continue in the study. "Survival" times need not relate to actual survival with death being the event; the "event" may be any event of interest. Kaplan-Meier analyses are also used in nonmedical disciplines. The purpose of this article is to explain how Kaplan-Meier curves are generated and analyzed. Throughout this article, we will discuss Kaplan-Meier estimates in the context of "survival" before the event of interest. Two small groups of hypothetical data are used as examples in order for the reader to clearly see how the process works. These examples also illustrate the crucially important point that comparative analysis depends upon the whole curve and not upon isolated points.

Sunnybrook facial grading system: reliability and criteria for grading.

OBJECTIVES/HYPOTHESIS: In clinical research, which is distinctly quantitative and rigidly fixed to a written protocol, the need for precision is great, especially when multicenter trials are planned. The Sunnybrook Facial Grading System (SB) is a well-established tool for assessing facial movement outcomes; however, some ambiguities do arise. The purpose of this study was to construct specific grading criteria and to test the intra-rater and inter-rater reliability before and after the use of these criteria. The hypothesis was that even in naïve observers, specific criteria improve reliability. STUDY DESIGN: Prospective test of hypothesis. METHODS: Facial video recordings of 30 subjects with facial paralysis were randomly presented to two naïve raters in four trials; trials 1 and 2 using the SB system in the usual manner, and trials 3 and 4 using specific grading criteria for the SB system. RESULTS: The SB system was reliable, even with naïve raters, having an intraclass correlation coefficient (ICC) of 0.890 between raters; this was improved with the use of specific grading criteria to 0.927. Additionally, variability of the SB composite scores was greatest in the midrange of scores and was predominantly seen during voluntary movement of brow rising and lip puckering. CONCLUSIONS: To our knowledge, this is the first report of specific criteria for completing the SB system. It is also the first in-depth description of the location within the system in which the majority of variances occur.

A practical guide to understanding systematic reviews and meta-analyses.

A systematic review is a transparent and unbiased review of available information. The published systematic review must report the details of the conduct of the review as one might report the details of a primary research project. A meta-analysis is a powerful and rigorous statistical approach to synthesize data from multiple studies, preferably obtained from a systematic review, in order to enlarge the sample size from smaller studies to test the original hypothesis and/or to generate new ones. The objective of this article is to serve as an easy to read practical guide to understand systematic reviews and meta-analyses for those reading them and for those who might plan to prepare them.

A practical guide for understanding confidence intervals and P values.

The 95 percent confidence interval about the mean demarcates the range of values in which the mean would fall if many samples from the universal parent population were taken. In other words, if the same observation, experiment, or trial were done over and over with a different sample of subjects, but with the same characteristics as the original sample, 95 percent of the means from those repeated measures would fall within this range. This gives a measure of how confident we are in the original mean. It tells us not only whether the results are statistically significant because the CI falls totally on one side or the other of the no difference marker (0 if continuous variables; 1 if proportions), but also the actual values so that we might determine if the data seem clinically important. In contrast, the P value tells us only whether the results are statistically significant, without translating that information into values relative to the variable that was measured. Consequently, the CI is a better choice to describe the results of observations, experiments, or trials.

Practical guide to efficient analysis and diagramming articles.

OBJECTIVE: In a busy practice, time is a commodity in rare supply, and keeping abreast of the relevant medical literature is a daunting task. Even after reading an article carefully, important information may be lost because of undue attention to the methodological minutia. METHOD: Fundamental to reducing a complex article into a well-organized and consistent format is the technique of quantitatively diagramming the principal components in the design and findings of the study. This approach allows a coherent brief summary statement of the article, and a platform for a focused scientific discussion and analysis of the clinical applicability of the findings. CONCLUSIONS: The technique of diagramming an article is a tool that the senior author has used for years and has found it valuable in capturing the scientific fundamentals of a manuscript. Once prepared, the diagram has proven to be useful in clarifying presentations during journal club, preparing the background and significance sections of grant applications, reviewing articles as a journal editor and as a journal reviewer, and easily retrieving documents to support evidence-based practice efforts.

Practical guide to understanding the value of case reports.

Case reports have been vital to the advancement of medicine, providing a mechanism for scholarly education and for sharing new discovery and rare observations. However, journals are increasingly reluctant to publish this type of manuscript. Additionally, case reports and limited case series are infrequently cited, potentially interfering with the impact factor of a journal. The increasing emphasis on evidence-based medicine may have artificially decreased the value of case reports. This article describes the value of case reports to medicine, citing 3 examples that have significantly improved the practice of medicine. We also provide criteria for effective reporting, which include the elements of both surprise and closure. In summary, we offer support for the contention that case reports are fundamental to the scholarly practice of medicine and enhance the intent of a quality medical journal.

In vivo estimates of the position of advanced bionics electrode arrays in the human cochlea.

OBJECTIVES: A new technique for determining the position of each electrode in the cochlea is described and applied to spiral computed tomography data from 15 patients implanted with Advanced Bionics HiFocus I, Ij, or Helix arrays. METHODS: ANALYZE imaging software was used to register 3-dimensional image volumes from patients' preoperative and postoperative scans and from a single body donor whose unimplanted ears were scanned clinically, with micro computed tomography and with orthogonal-plane fluorescence optical sectioning (OPFOS) microscopy. By use of this registration, we compared the atlas of OPFOS images of soft tissue within the body donor's cochlea with the bone and fluid/ tissue boundary available in patient scan data to choose the midmodiolar axis position and judge the electrode position in the scala tympani or scala vestibuli, including the distance to the medial and lateral scalar walls. The angular rotation 0 degrees start point is a line joining the midmodiolar axis and the middle of the cochlear canal entry from the vestibule. RESULTS: The group mean array insertion depth was 477 degrees (range, 286 degrees to 655 degrees). The word scores were negatively correlated (r = -0.59; p = .028) with the number of electrodes in the scala vestibuli. CONCLUSIONS: Although the individual variability in all measures was large, repeated patterns of suboptimal electrode placement were observed across subjects, underscoring the applicability of this technique.