Communication clinical

According to the U.S. Department of Health and Human Services, 1.4 million cases of child maltreatment are reported annually, with 160,000 children suffering serious injuries and 2000 children dying each year as a consequence of maltreatment. Prevalence rates have been evaluated for different types of abuse in clinical, community, and national samples. Prevalence rates of sexual abuse range from 7%-62% in women (McCauley et al., 1997). A reanalysis of 166 studies on the prevalence of sexual abuse in boys revealed rates from... 

The greater ease of clinical communication about biomarkers and health than of other biomonitoring communication comes with several caveats. First, not all clinical communication involves people who were study subjects for example, announcement of local (if not national) surveillance results might prompt members of the wider population to visit their doctors for consultation. The experience of environmental-risk assessors in communicating the distinction between population risks (the usual focus of risk estimates) and individual risks does not augur well for either professionals ability to communicate the difference well or constituents ability to comprehend. Second, some people subject to biomonitoring (including those... 

Center for Devices and Radiological Health (CDRH), Guidance for Industry, Review Staff, and the Clinical Community, Guidance on Criteria and Approaches for Postmarket Surveillance, Nov. 2,1998. 

Presenting the results of a clinical study to a regulatory agency in a clinical study report and presenting the results to the clinical community in journal publications. 

Statistical analyses result in a test statistic being calculated. For example, two common tests that will be introduced in this chapter are the f-test and a test called analysis of variance (ANOVA). The /-tests result in a test statistic called /, and ANOVA results in a test statistic called F. When you read the Results sections of regulatory submissions and clinical communications, you will become very familiar with these test statistics. The test statistic obtained determines whether the result of the statistical test attains statistical significance or not. 

The number of clinical communications published per year has increased to staggering proportions. Matthews (2006) noted that there are currently on the order of20,000 biomedical journals that publish on the order of two million articles a year. This makes it extremely difficult for a clinician who would like to research a particular topic to locate all of the relevant articles. Accordingly, two kinds of review papers can be very helpful. The first is narrative reviews. These collate, compare, discuss, and summarize the current state of knowledge (Matthews, 2006). Narrative reviews are descriptive in nature. The second kind of review incorporates meta-analysis. These reviews are quantitative in nature. 

Relatedly, once a drug has been marketed and has proved to be successful (clinically successful as indicated in published clinical communications and likely commercially successful as evidenced by annual sales reports), other companies may wish to develop similar products that they feel will have a clinical (and commercial) advantage. This process involves the development of an analog of the established drug (see Fischer and Ganellin, 2006). 

In addition to preparing and submitting documentation to regulatory agencies, the results of clinical studies are reported to the scientific and clinical communities via clinical communications published in medical journals. It was noted in Chapter 1 that presenting the results of a clinical study to the clinical community falls under the scope of this book s expanded definition of Statistics. This section briefly reviews the skills necessary to write good clinical publications and also introduces the peer-reviewed publishing process. 

Throughout this book there has been an emphasis on the acquisition of optimum quality data. As well as presenting this optimum quality data to regulatory agencies, it is imperative to present optimum quality data to readers of the clinical literature. It is of the utmost ethical importance that clinical communications are prepared to the highest degree of science and ethics, since clinicians may base the treatment of individual patients on evidence published in clinical communications in their practice of evidence-based medicine (see Section 13.7). 

There are two components to evidence-based medicine and two related sets of responsibilities. The first component is clinical research. Clinical research is a scientific endeavor that provides evidence concerning potential therapeutic interventions. This book has focused on one particular therapeutic intervention, drug therapy. Once clinical trials have been conducted, the evidence obtained is published in clinical communications in journals. Everyone involved in clinical research has the responsibility to provide the best possible evidence in this manner. As noted throughout the book, this includes all aspects of clinical research study design, experimental methodology and clinical operations, analysis and interpretation, and also accurate and complete representation of study findings in clinical communications as discussed in Section 13.6. 

The second component of evidence-based medicine is clinical practice (see also Mayer, 2004 Straus et al., 2005). Clinicians have the responsibility of providing the best possible care to each of their individual patients. One part of being able to provide this optimum care is remaining aware of pertinent evidence that is published in clinical communications (as mentioned in the previous section, this is no small task). It is also incumbent on clinicians to be able to decide for themselves if the evidence presented in a clinical communication is good evidence and if the message of a systematic review or a meta-analysis is justified based on the quality of the report. As Katz (2001) commented ... 

Authors have an ethical responsibility to report information accurately and fully in clinical communications, since these directly impact patient care. 

Walsh B, Maguire H, Carrington D. Outbreak of hepatitis B in an acupuncture clinic. Commun Dis Public Health... 

Benjamin Freedman (1951-1997) defined clinical equipoise as a state of genuine uncertainty on the part of the investigator [or - present or imminent controversy in the clinical community] regarding the comparative therapeutic merits of each arm in a trial . Freedman continued that at the start of the trial, there must be a state of clinical equipoise regarding the merits of the regimens to be tested, and the trial must be designed in such a way as to make it reasonable to expect that, if it is successfully conducted, clinical equipoise will be disturbed . 

For many pharmacists, their first encounter with the terminology quality of life was in the 1986 New England Journal of Medicine article by Croog et alJ entitled The effects of hypertensive therapy on the quality of life. The authors found that antihypertensive agents had different effects on the quality of life and that these differences can be meaningfully assessed with available psychosocial measures. Currently, the clinical community is more aware of patient-based measures and the potential uses of health status assessments. Curriculum of many schools of pharmacy now includes some information on outcomes of patient care beyond just the traditional biological measures. 

This functional definition makes clear that the discipline of Statistics is Indeed multi-faceted and essential throughout clinical trials. It is critical at the start of the clinical trial process so that a study can be designed appropriately to facilitate the collection of optimum quality data, which then need to be organized and managed correctly. These data are then described and analyzed, and the numerical results of these analyses are interpreted in the context of the particular study. Finally, the numerical results of the analyses and the authors interpretation of these results are presented to regulatory agencies to request permission to market the drug, and published in clinical communications to provide Information to physicians. 

Sponsors typically publish the results of important clinical trials in clinical communications in medical journals, and present the results at scientific conferences. As for the preparation of regulatory documentation, scientific communications depend heavily on the discipline of Statistics. Piantadosi (2005) made the following comment about publishing clinical communications ... 

While the format of clinical communications is different from the format of clinical study reports that are submitted to regulatory agencies, the discipline of Statistics provides the basis for the approach taken. A typical format for a clinical communication is ... 

The purpose of clinical research is to provide information that guides clinical practice. Clinical communications are read by physicians who use the information provided when deciding whether a particular treatment might be appropriate for an individual patient. These articles are... 

Guidelines for reporting clinical trials in clinical communications are provided by the Consolidated Standards of Reporting Trials (CONSORT) group. We recommend that you read the CONSORT statements (see www. consort-statement, org). We also refer you to Bowers et al. (2006) and Stuart (2007) for extensive coverage of this topic. 

Describe the ethical considerations in preparing clinical communications. 

During the last decade, MRS examination received only scant attention from the clinical community. This was pardy because MRS did not produce anatomic images, but resulted in graphs, and it could only be obtained with dedicated units and software (Castillo et ai, 1996). At present, MRS may be carried out at almost all clinical MR units with a field strength of 1.5T or higher and in time periods as short as 10—15 min. Therefore, it may be added to routine MR imaging studies without significant time penalties to obtain information on tissue characterization. 

---