Think about why you are writing the report. The most common reasons for writing a report are:
° to inform (presenting facts and figures)
° to influence (providing evidence that will persuade another person to take a specific course of action)
° to advise (offering recommendations)
° to explain (presenting interpretations)
° to record (documenting a contact)
° to summarise (providing a synopsis of the main points).
Sunday, August 22, 2010
Saturday, August 21, 2010
Drug Development
This process starts with the synthesis of novel chemical compounds. Substances with complex structures may be obtained from various sources, e.g., plants (cardiac glycosides), animal tissues (heparin), microbial cultures (penicillin G), or human cells (urokinase), or by means of gene technology (human insulin).
As more insight is gained into structure-activity relationships, the search for new agents becomes more clearly focused. Preclinical testing yields information on the biological effects of new substances. Initial screening may employ biochemical-pharmacological investigations (e.g., receptor-binding assays p. 56) or experiments on cell cultures, isolated cells, and isolated organs. Since these models invariably fall short of replicating complex biological processes in the intact organism, any potential drug must be tested in the whole animal. Only animal experiments can reveal whether the desired effects will actually occur at dosages that produce little or no toxicity. Toxicological investigations serve to evaluate the potential for:
(1) toxicity associated with acute or chronic administration; (2) genetic damage (genotoxicity, mutagenicity); (3) production of tumors (onco- or carcinogenicity); and (4) causation of birth defects (teratogenicity). In animals, compounds under investigation also have to be studied with respect to their absorption, distribution, metabolism, and elimination (pharmacokinetics). Even at the level of preclinical testing, only a very small fraction of new compounds will prove potentially fit for use in humans.
Pharmaceutical technology provides the methods for drug formulation. Clinical testing starts with Phase I studies on healthy subjects and seeks to determine whether effects observed in animal experiments also occur in humans. Dose-response relationships are determined. In Phase II, potential drugs are first tested on selected patients for therapeutic efficacy in those disease
states for which they are intended. Should a beneficial action be evident and the incidence of adverse effects be acceptably small, Phase III is entered, involving a larger group of patients in whom the new drug will be compared with standard treatments in terms of therapeutic outcome. As a form of human experimentation, these clinical trials are subject to review and approval
by institutional ethics committees according to international codes of conduct (Declarations of Helsinki, Tokyo, and Venice). During clinical testing, many drugs are revealed to be unusable. Ultimately, only one new drug remains from approximately 10,000 newly synthesized substances.
The decision to approve a new drug is made by a national regulatory body (Food & Drug Administration in the U.S.A., the Health Protection Branch Drugs Directorate in Canada, UK, Europe, Australia) to which manufacturers are required to submit their applications.
Applicants must document by means of appropriate test data (from preclinical and clinical trials) that the criteria of efficacy and safety have been met and that product forms (tablet, capsule, etc.) satisfy general standards of quality control.
Following approval, the new drug may be marketed under a trade name (p. 333) and thus become available for prescription by physicians and dispensing by pharmacists. As the drug gains more widespread use, regulatory surveillance continues in the form of postlicensing studies (Phase IV of clinical trials). Only on the basis of long-term experience will the risk: benefit ratio be
properly assessed and, thus, the therapeutic value of the new drug be determined.
As more insight is gained into structure-activity relationships, the search for new agents becomes more clearly focused. Preclinical testing yields information on the biological effects of new substances. Initial screening may employ biochemical-pharmacological investigations (e.g., receptor-binding assays p. 56) or experiments on cell cultures, isolated cells, and isolated organs. Since these models invariably fall short of replicating complex biological processes in the intact organism, any potential drug must be tested in the whole animal. Only animal experiments can reveal whether the desired effects will actually occur at dosages that produce little or no toxicity. Toxicological investigations serve to evaluate the potential for:
(1) toxicity associated with acute or chronic administration; (2) genetic damage (genotoxicity, mutagenicity); (3) production of tumors (onco- or carcinogenicity); and (4) causation of birth defects (teratogenicity). In animals, compounds under investigation also have to be studied with respect to their absorption, distribution, metabolism, and elimination (pharmacokinetics). Even at the level of preclinical testing, only a very small fraction of new compounds will prove potentially fit for use in humans.
Pharmaceutical technology provides the methods for drug formulation. Clinical testing starts with Phase I studies on healthy subjects and seeks to determine whether effects observed in animal experiments also occur in humans. Dose-response relationships are determined. In Phase II, potential drugs are first tested on selected patients for therapeutic efficacy in those disease
states for which they are intended. Should a beneficial action be evident and the incidence of adverse effects be acceptably small, Phase III is entered, involving a larger group of patients in whom the new drug will be compared with standard treatments in terms of therapeutic outcome. As a form of human experimentation, these clinical trials are subject to review and approval
by institutional ethics committees according to international codes of conduct (Declarations of Helsinki, Tokyo, and Venice). During clinical testing, many drugs are revealed to be unusable. Ultimately, only one new drug remains from approximately 10,000 newly synthesized substances.
The decision to approve a new drug is made by a national regulatory body (Food & Drug Administration in the U.S.A., the Health Protection Branch Drugs Directorate in Canada, UK, Europe, Australia) to which manufacturers are required to submit their applications.
Applicants must document by means of appropriate test data (from preclinical and clinical trials) that the criteria of efficacy and safety have been met and that product forms (tablet, capsule, etc.) satisfy general standards of quality control.
Following approval, the new drug may be marketed under a trade name (p. 333) and thus become available for prescription by physicians and dispensing by pharmacists. As the drug gains more widespread use, regulatory surveillance continues in the form of postlicensing studies (Phase IV of clinical trials). Only on the basis of long-term experience will the risk: benefit ratio be
properly assessed and, thus, the therapeutic value of the new drug be determined.
Saturday, August 14, 2010
The Nature of Written Communication
The written word, like spoken communication, is used for a variety of functions. Just a few of these are listed below:
° to instruct
° to inform
° to express ideas or an opinion
° to direct
° to debate and discuss
° to persuade
° to develop logical ideas
° to describe
° to entertain
° to hypothesise
° to summarise
° to list. All of the above can be equally applied to spoken language. So what is it about the nature of the written word that often gives it preference over speech?
The written word offers a more enduring form of communication than the spoken word. This makes it an ideal choice for recording information, so that it can be referred to repeatedly and preserved over a long period of time.
Duplicates of letters, reports and other documents are easily produced. This allows sharing of information amongst a range of people who do not have to be present to witness the original
communication.
à The writer has more time to organise his or her thoughts and assemble complex facts and figures. There is time to review the intended message and redraft if necessary.
à Writing is often the first choice when formality is required. A formal letter or report will indicate to the recipient the seriousness of the matter under discussion.
It is important to remember that writing differs significantly from spoken language. In speech, additional meaning and information are often conveyed through the body language or vocal characteristics of the speaker. This element of communication is absent from the written message. The writer needs to use skill and creativity in order to achieve the same depth of meaning and nuance as the spoken message.
Also, text is often read separately in time and place from the people and events to which it relates. There is a lack of immediate feedback about the level of the reader’s interest, understanding and involvement. The written word must make sense away from the context to which it refers. The onus is on the writer to provide all the necessary information required by the reader, and to modify vocabulary and language to meet the anticipated needs of the reader.
Despite some drawbacks, the written word continues to be one of the main methods of communication within the health service. The next chapter identifies the key elements in communicating effectively using writing.
° to instruct
° to inform
° to express ideas or an opinion
° to direct
° to debate and discuss
° to persuade
° to develop logical ideas
° to describe
° to entertain
° to hypothesise
° to summarise
° to list. All of the above can be equally applied to spoken language. So what is it about the nature of the written word that often gives it preference over speech?
The written word offers a more enduring form of communication than the spoken word. This makes it an ideal choice for recording information, so that it can be referred to repeatedly and preserved over a long period of time.
Duplicates of letters, reports and other documents are easily produced. This allows sharing of information amongst a range of people who do not have to be present to witness the original
communication.
à The writer has more time to organise his or her thoughts and assemble complex facts and figures. There is time to review the intended message and redraft if necessary.
à Writing is often the first choice when formality is required. A formal letter or report will indicate to the recipient the seriousness of the matter under discussion.
It is important to remember that writing differs significantly from spoken language. In speech, additional meaning and information are often conveyed through the body language or vocal characteristics of the speaker. This element of communication is absent from the written message. The writer needs to use skill and creativity in order to achieve the same depth of meaning and nuance as the spoken message.
Also, text is often read separately in time and place from the people and events to which it relates. There is a lack of immediate feedback about the level of the reader’s interest, understanding and involvement. The written word must make sense away from the context to which it refers. The onus is on the writer to provide all the necessary information required by the reader, and to modify vocabulary and language to meet the anticipated needs of the reader.
Despite some drawbacks, the written word continues to be one of the main methods of communication within the health service. The next chapter identifies the key elements in communicating effectively using writing.
Introduction
One of the main methods of communication within the health service is the written word, whether this is in the form of clinical notes, reports or letters. An increasing emphasis is being placed on improving and maintaining the quality of such communications. This means the written output of clinicians is under more rigorous scrutiny than ever before.
The first part of this book offers practical guidance in developing the effective writing skills required in everyday clinical practice. It will be useful for students learning about clinical documentation and for practitioners wishing to review their writing practices.
Training, teaching and continuing education are essential in the development of a skilled workforce in the health service. All clinicians are involved in this process, first as students then later as experienced clinicians mentoring or training others. The second part of this book addresses the various writing demands arising in such teaching and learning contexts. It covers topics as far-ranging as effective note-taking, preparing teaching materials and writing up research.
The final part of the book is dedicated to writing for publication. There are many opportunities for health professionals to place their written work in the public arena. Writing books and journal articles provides an opportunity for disseminating information, sharing best practice and stimulating debate. It contributes to the knowledge base of the profession and helps maintain the dynamic nature of the care process. Becoming a published author is also a great personal achievement, and this section offers advice on how, what and where to publish.
This book is intended for use by a variety of health care workers that includes therapists, health visitors, nurses and general practitioners.
The first part of this book offers practical guidance in developing the effective writing skills required in everyday clinical practice. It will be useful for students learning about clinical documentation and for practitioners wishing to review their writing practices.
Training, teaching and continuing education are essential in the development of a skilled workforce in the health service. All clinicians are involved in this process, first as students then later as experienced clinicians mentoring or training others. The second part of this book addresses the various writing demands arising in such teaching and learning contexts. It covers topics as far-ranging as effective note-taking, preparing teaching materials and writing up research.
The final part of the book is dedicated to writing for publication. There are many opportunities for health professionals to place their written work in the public arena. Writing books and journal articles provides an opportunity for disseminating information, sharing best practice and stimulating debate. It contributes to the knowledge base of the profession and helps maintain the dynamic nature of the care process. Becoming a published author is also a great personal achievement, and this section offers advice on how, what and where to publish.
This book is intended for use by a variety of health care workers that includes therapists, health visitors, nurses and general practitioners.
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