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Principle 201 99m Current literature on the clinical use of Tl chloride or Tc-sestamibi supports their usefulness for tumour localization in general and for intracranial lesions in particular purchase bupron sr 150 mg with amex depression exhaustion. Clinical indications Imaging is required for the following purposes: (a) Differentiation of tumour recurrence from oedema bupron sr 150 mg with amex depression scale definition, fibrosis or necrosis post-treatment; (b) Evaluation of tumour response to various kinds of treatment; (c) Differentiation of benign opportunistic infection lesions from malignant intracranial lesions in both immunosuppressed and non-immunosuppressed patients buy bupron sr master card depression definition mental illness. Use of Tc-sestamibi is encouraged in paediatric patients because of higher injected dose, less radiation burden and better physical characteristics. In paraventricular lesions, 201 Tl chloride is preferred because of physiological choroid plexus and pituitary uptake with 99mTc-sestamibi. Protocols The following protocols should be made: (a) Patient preparation (i) No special recommendation such as fasting or stopping medications is needed. Studies can be performed after a few days of chemo- therapy or radiotherapy but are not advisable in the immediate post- operative period. Patients having antibiotic treatment for toxoplasmosis might give a false positive. Previous radiation therapy, chemotherapy or surgery, and the time period from the current study should be specifically mentioned. Image acquisition Attention should be paid to the following points: (a) Waiting time after injection Imaging can start at any time after a 15 min waiting period from 201 99m intravenous injection of either Tl or Tc-sestamibi. In the case of differentiation of post-operative changes, oedema or inflammation, from residual tumour or recurrence, delayed images after a minimum of two hours from the time of injection of the radiopharmaceuticals are essential. If the patient’s cooperation is unsatisfactory, sedation may be used according to the previous guidelines. This can be achieved either by two dimensionally prefiltering the projection data or by applying a 3-D post-filter to the reconstructed data. Resolution recovery or spatially varying filters should be used with caution, as they may produce artefacts. If slices are to be summed, this should be done after reconstruction and oblique orientation (if performed). Attenuation correction is encouraged especially in paraventricular lesions and in the presence of low-grade lesion uptake. Each institution should develop its own technique for calculating the lesion-to-background ratio. Paraventricular small lesions (especially with 99mTc-sestamibi) must be interpreted with caution, as well as lesions close to the calvarium, the petrous bone, the temporal bone, the cribriform plate in the base of the anterior cranial fossa and near the orbits. Benign lesions such as tuberculosis, histiocytosis, sarcoidosis and brain abscesses may produce high intensity uptakes. Low grade gliomas can show no uptake of either radiopharmaceutical and be the cause of false negatives. In post-operative studies, interpretation can be improved by taking into consideration the site, extent, intensity and location of the abnormal uptake, and also by comparing the early (if available) and delayed images. A negative study following recent treatment does not indicate that a disease has been cured. It only indicates a good response and does not exclude microscopic residual disease. If the studies are performed for the purpose of differentiation of intra- cranial toxoplasmosis from lymphoma in the immunosuppressed patient, recent treatment for toxoplasmosis might produce a false positive uptake. Reporting The report should include the radiopharmaceutical used, dose, route of injection, waiting period, clinical history and the reason for referring the patient for the study. If sedation has been given it should be mentioned, as well as any adverse reactions. The report should include and mention the findings of other morpho- logical imaging modalities and their correlation with the nuclear medicine procedure. The intensity of uptake should be graded as low, medium or high, together with the size of the lesion as accurately as possible, and its location. Principle The trinity of metabolism–function–blood-flow of the brain are closely interrelated. The subtraction of rest images from activated images enables a clearer identification of activated regions of the brain. Activation paradigms include visual, audio and finger motion stimulations as well as speech and thinking. Activation studies may elucidate higher brain functions in healthy volunteers and neuropsychiatry patients. Clinical indications The indications are the same as those for the cerebral perfusion studies (Section 5. Radiopharmaceuticals Positron emitting radiopharmaceuticals are used for metabolic imaging. Three aspects of cerebral metabolism are of interest clinically, namely glucose and oxygen utilization and protein synthesis. Oxygen-15-O2 can be continuously inhaled, with little dissolved in plasma and most bound to haemoglobin. It is 15 the bound portion of O that is transported to, and utilized by, the brain. Carbon-11-methionine shows protein synthesis and is used mainly for brain tumour imaging. Protocols Patient preparation and pre-test precautions are similar to those described for perfusion. Because of the very short half-life of radionuclides, brain metabolic imaging may be repeated at short intervals to facilitate assessment of different brain states. Acquisition is usually accompanied by a transmission session for attenuation correction. If a kinetics analysis is required, dynamic or fast repeated acquisi- tions are needed. Data processing and interpretation Cerebral metabolic images are similar to those of cerebral perfusion. Usually the metabolic and perfusion images are similar in pattern under normal circumstances. Metabolic images should be interpreted with the structural data available, and co-registration techniques are of great value. Clinical indications Most receptor–transporter studies have been performed to evaluate movement disorders, epilepsy and psychiatric illnesses, but clinical indications are still investigational. Radiopharmaceuticals The radiotracers used in the functional imaging of the brain are listed in Table 5. Protocol Preparation, basic requirements and operational procedures are almost identical to those used in perfusion and metabolic studies. Intervention, for example audiovisual stimulation, task performance tests and complicated conditioning, are more widely used in neuroreceptor studies.
Diseases
Omissions of details in ceutical physicians may benefit from some discus- methods and results pursuant to a concise presen- sion of classic parts of an orthodox clinical trial tation will always be subjective purchase bupron sr 150mg without a prescription anxiety yoga poses, and there is a close report in a peer-reviewed journal purchase 150 mg bupron sr fast delivery klinische depression test, and some clues link between the appropriateness of this subjectiv- for effective oral presentations buy bupron sr 150 mg online depression test boots. The scope of this chapter is whether writing him/herself or when guiding spe- strictly formal publications: regulatory documents cialist medical writers, are many, sometimes con- (which are typically not published and are a differ- trary to common standards of integrity, and often ent form of clinical trials reporting)and marketing emanate from powerful people who lack the materials are dealt with elsewhere. In some way or another, the pharmaceutical used by journalists, the diligent application of com- physician will interpret his/her data to reach con- plete ignorance, and the forced fit of technical in- clusions, and will want to urge some change in the formation to a predetermined political position. These changes The publication of clinical trials, then, is one might include prescribing habits, healthcare re- example where the pharmaceutical physician source utilization, public health policy, or regula- (acting as publicist or medical writer)may become tory practices. Even when Whatever the form of publication, the only tools he/she acts solely as a medical writer, the pharma- available to persuade people to make these behav- ceutical physician must understand the ethical re- ioural changes are the well-created document, sponsibility to represent the material in a fair, audiovisual presentation, press release, etc. If this under-reporting is suboptimal, then those Regulators controlling promotional practices need who publish clinical trials must take their share of only satisfy themselves that the publication accur- the blame. Marketing depart- publish negative data that are making the most ments can use these publications for promotional noise about how unsatisfactory is the performance purposes, knowing that the data is cast-iron, the of the pharmaceutical industry in failing to publish message is unarguably positive, and that the self- it (e. This evident benefits of the drug will be understood by author cannot agree with Dickersin et al (1992), the most sceptical clinician meeting the least adept who wrote: `Contrary to popular opinion, publica- salesperson. Lastly, senior management can bask in tion bias originates primarily with investigators, the glory of its contribution to the public health, not journal editors. Two Lastly, some good studies are less than ideal publi- large pharmaceutical companies have taken an ini- cation candidates solely because the manuscript tiative to register their own clinical trials (e. All too often the primary objective should identify the target journal before putting of the trial is not achieved: the authors then select- pen to paper, and judge whether the quantity of ively publish a few of the many secondary end- material supports a whole paper, a brief report, or points that did support their hypothesis. Clinical trials are a an independently-prepared summary of the proto- specific case of this general, perennial problem, to col, with its prospective objectives and complete list which Rafal (1991)has provided a somewhat of end-points, perhaps in mini-type, at the end of humourous guide. The principal investigator(s)is(are)authors, cists, medical writers, and those who control unless so numerous as to require a team desig- journal content. The statistician(s)who personally accept(s)re- structing meta-analyses from published studies sponsibility for the statistical analysis in the should beware. All named authors should be able to personally The publication of clinical trials in peer-reviewed defend the paper after publication, and be fa- journals normally follows the same format as for miliar with (but not necessarily have personally any other paper: title, authors, sponsorship, ab- performed)all the methods employed in the stract, introduction, methods, results, discussion, clinical trial. All journals publish guidelines describing the The acknowledgments can then list all those formats for the often diverse types of article that who took part (e. A hybrid vari- academic meetings with: (a)disorganized speech ant is also sometimes used, where a one (or a few) (due to disordered thought processes and/or acute lead author(s)are named and stated to represent episodic dysarthria); and (b) an inability to control the rest of the team (e. This ineptitude is displayed by all advantages of this tactic are that there is at least medical specialties (including pharmaceutical phys- one person who accepts responsibility for defense icians and clinical trialists), by most other non- of the paper after publication. Some hosts make the talk more challen- multisite studies: the protocol can state that the ging by impishly providing slide projectors with investigator who recruits the most completed pa- various diseases (Fox 2000). You exclusion criteria in most clinical protocols alone should have the following three things sine qua non: exceed the word limit of most isolated abstracts. An understanding of the audience and the vo- is a criterion used by companies to justify the time cabulary needed to communicate with them and expense of sending staff to a conference: (the general public, a patient advocacy group, authors then generate and submit unimportant ab- an academic society, and an in-house depart- stracts, principally for use as tickets to venues that ment seminar all require very different ap- attract them for ulterior reasons. A look at the venue and the various pieces of published in full sometimes can make a isolated equipment that will be at your disposal; think abstract, provided the full reference is provided, about how to match your speaking volume to and an educated audience at, say, an academic the open air or to the microphone (if any), and conference, will be aware of the potential biases where to stand so that you can see your slides of this technique. But For the actual talk itself, one useful checklist is as these are minor exceptions to the general principle follows: that, in order to assess the validity of a clinical trials report, far more detail is needed than can be pub- 1. Create slides to be self-supporting: if you gave the central question be answered for that clinical your set of slides to someone equipped with a trial: would electronic publication make these data projector, could they, without any further ex- more easily available to the audience that can best planation, more or less work out your subject use them (Geddes 1999)? Practice search times, and has lower production and ship- showing one slide before wrongly loading all ping expenses, but requires readers to have access of them. Epidemiological patient population included 30% adolescents studies, where huge numbers of patients are often because this group represents a relevant frac- studied, may be especially suited to this form of tion of the whole population with type I dia- publication. The most common form at present is briefly review the data that you have pre- probably the distribution of electronic facsimiles of sented in their support, and then interpret printed papers, usually in. Access to these fac- similes is usually restricted to those who also have a Most people are in an altered psychological state subscription to the paper version of the journal, shortly after giving a talk, whether or not it seemed and thus represents a duplication of, or extension to go well. Pharmaceutical physicians may often want to Song et al (1999)have suggested that electronic avoid involvement in the drafting of press releases journals can reduce publication bias (see above), altogether. Altman (1999)have even proposed that not only The best advice on press releases may be two- will publication bias be reduced, but also the intrin- fold. However, this enlarged was the case, then state clearly the implications volume of publications also mandates a different of these data to the clinical development plan: if peer-review system, or even no peer-review at all. It it needs redirection, then state what that redirection is possible that electronic publications may come to is, and the implication for the registration time- be suspected as both providing higher quantities of line. This protection of the right to exploit companies will only very rarely be exposed to the a publication is central to the promotion of pub- need for press releases concerning their clinical lishing per se, and thus an incentive to disseminate trials. First, for a fee, the protected publica- ination of the results of such a clinical trial to the tion can be registered with the national office of appropriate audience (shareholders and investment copyright. Second, the copyright holder can simply community)is legally required when material to the assert in the publication ownership of copyright prospects of a small, public company. Extended detailed Law alternative can also be legally enforced, but explanations can actually create the false impres- requires the development of a set of evidence; an sion that the drug did not work, when in fact the infringer usually has at least an initial defence that trial outcome was quite satisfactory for product due search of the national register failed to locate registration purposes. Almost all journals require transfer of copy- have confidence in our ability to register Drug X; right from authors to publisher upon acceptance of Drug X performed as we expected, but it was just submitted manuscripts. Some pharmaceut- publisher to use his own manuscript later; in prac- ical companies are beginning to provide such regis- tice, this permission is routinely granted upon writ- tries for their own work, but no internationally ten application. It is possible that electronic his/her own work, and which leaves copyright own- publication can improve this situation, but, at pre- ership with the author(s); the license can also sent, there is more optimism than proof that this is become void if the publisher fails to exploit it, and the case. Systems for publi- McConnell J, Horton R (1999)Lancet electronic research cation of clinical trials are currently neither com- archive in international health and eprint server. The Subcutaneous Sumatriptan International Study Group Song F, Eastwood A, Gilbody S, Duley L (1999)The role of (1991)Treatment of migraine attacks with sumatriptan. Perhaps ranty claims against pharmaceutical companies, the most fundamental feature of contractural li- based on statements made in the package insert 4 ability is that it is strict and not fault-based. The pharmaceutical physician will be very famil- This is likely to contain terms which, if broken by iar with certain types of contracts, depending on the individual, could give rise to a claim being made his/her role within the company. Generally, there is no contract between the Distinct from the law of contract, the law of tort pharmaceutical company and the patient who is serves to regulate standards of behaviour, operat- prescribed the product by a doctor. However, it may be that the contract had a duty of care to the ultimate consumer of its between the manufacturer and the retailer contains product to take reasonable care in the manufacture 9 an indemnity provision. Therefore, some In order to succeed in a claim of negligence, a courts have carved out an exception to the privity plaintiff must prove all three elements. It must be proved that the defendant As any pharmaceutical physician is well aware, the was at fault in that he/she acted wrongfully and as development, manufacture, marketing and safety a result violated a right of the plaintiff, causing of pharmaceutical products are subject to close harm to him/her. The gov- differentiates a genuine accident from a negligent ernment exercises control through specific regula- act for which the injured person can be compen- tions on the sale of medicines and medical devices. Pharmaceutical physicians play a key role in ensur- To complicate matters, however, in some coun- ing that, at each stage in the life of a pharmaceut- tries, liability may also arise in tort without proof of ical product, the regulatory requirements have fault. As discussed above, there may be crim- example of strict liability for pharmaceutical com- inal implications for the applicant for a licence if panies is what is commonly referred to as the certain of the requirements are not fulfilled. The Directive has to be more individual employees to comply with the implemented in each European country through regulations may be relevant to the question of national legislation and, as a result, the law in whether or not a company had acted reasonably.
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