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In the social sciences there appear to buy samsca with american express be two approaches to order 15mg samsca free shipping establishing the validity of a research instrument buy cheap samsca 15mg line. These approaches are based upon either logic that underpins the construction of the research tool or statistical evidence that is gathered using information generated through the use of the instrument. Establishing validity through logic implies justification of each question in relation to the objectives of the study, whereas the statistical procedures provide hard evidence by way of calculating the coefficient of correlations between the questions and the outcome variables. Establishing a logical link between the questions and the objectives is both simple and difficult. It is simple in the sense that you may find it easy to see a link for yourself, and difficult because your justification may lack the backing of experts and the statistical evidence to convince others. Establishing a logical link between questions and objectives is easier when the questions relate to tangible matters. For example, if you want to find out about age, income, height or weight, it is relatively easy to establish the validity of the questions, but to establish whether a set of questions is measuring, say, the effectiveness of a programme, the attitudes of a group of people towards an issue, or the extent of satisfaction of a group of consumers with the service provided by an organisation is more difficult. When a less tangible concept is involved, such as effectiveness, attitude or satisfaction, you need to ask several questions in order to cover different aspects of the concept and demonstrate that the questions asked are actually measuring it. Validity in such situations becomes more difficult to establish, and especially in qualitative research where you are mostly exploring feelings, experiences, perceptions, motivations or stories. It is important to remember that the concept of validity is pertinent only to a particular instrument and it is an ideal state that you as a researcher aim to achieve. Types of validity in quantitative research There are three types of validity in quantitative research: 1. Face and content validity the judgement that an instrument is measuring what it is supposed to is primarily based upon the logical link between the questions and the objectives of the study. Hence, one of the main advantages of this type of validity is that it is easy to apply. Each question or item on the research instrument must have a logical link with an objective. It is equally important that the items and questions cover the full range of the issue or attitude being measured. Assessment of the items of an instrument in this respect is called content validity. In addition, the coverage of the issue or attitude should be balanced; that is, each aspect should have similar and adequate representation in the questions or items. Content validity is also judged on the basis of the extent to which statements or questions represent the issue they are supposed to measure, as judged by you as a researcher, your readership and experts in the field. Although it is easy to present logical arguments to establish validity, there are certain problems: the judgement is based upon subjective logic; hence, no definite conclusions can be drawn. Different people may have different opinions about the face and content validity of an instrument. If the researcher substitutes one question for another, the magnitude of the link may be altered. Hence, the validity or its extent may vary with the questions selected for an instrument. Concurrent and predictive validity ‘In situations where a scale is developed as an indicator of some observable criterion, the scale’s validity can be investigated by seeing how good an indicator it is’ (Moser & Kalton 1989: 356).

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Professor Gutter now aims to samsca 15 mg lowest price further improve the transplant procedures by using a new buy discount samsca 15mg, small surgical instrument that might reduce blood loss during surgery discount 15mg samsca with amex. This pilot trial will include five liver transplant donors, and Professor Gutter will serve as the lead surgeon and principal investigator. Comments to Clinical Trial Insurance Scenario 1 In this scenario, the industry sponsor plans to test a new concentrated ginseng extract in 20 geriatric participants. Ginseng extract has been used for decades – even centuries – as a traditional treatment, especially in the elderly or in patient groups with diminished quality of life. One could thus argue that ginseng is a documented safe herbal extract, since its safety profile has been proven through extensive usage. Documented side-effects of ginseng include nervousness, excitability, decreased ability to concentrate, decreased blood sugar levels, an estrogen-like effect, and, in a few reported cases, asthma attacks and increased level of blood pressure. However, the ginseng test article to be studied is not the same as traditionally used ginseng extract, since it has been refined and is highly concentrated. The side-effect profile of this new ginseng extract has not yet been defined in humans, and the risk can thus be seen as more than minimal. Comments to Clinical Trial Insurance and Indemnity Scenario 2 Professor Koyama and his colleagues have developed a new biogenic injectable bone cement that is expected to prevent/reduce the amount of pain experienced by patients with collapsed spinal vertebra. Scenarios of Ethics Committee Review 131 copy of a valid clinical trial insurance policy in line with the current institutional policies in this issue. Note: the cost of medical device clinical trial insurance is usually higher than the cost for drug trials. Medical devices are commonly exempted from an institutional master clinical trial insurance policy. Just to make it clear, each of the three corticosteroids is labeled for use in patients with rhinitis, but not in combination with each other. Note: Indemnity issues related to clinical trials have different implications in countries with efficient, low-cost public health care, compared to countries without a similar health care system. Comments to Clinical Trial Insurance and Indemnity Scenario 4 Professor Gutter is an expert in liver transplant surgery. She has proposed a new surgical liver transplant procedure for donors that may reduce blood loss during surgery. This trial comes with high risk, since it will test a new surgical procedure in normal participants during a partial liver transplant operation. The surgery itself is risky and the new surgical procedure has not yet been proven to be beneficial and safe. Some institutions would say that an insurance policy must be in place for similar investigator-initiated surgical procedure trials, while other institutions might not. Note: When there is no indemnification guarantee and policy insurance in place, the potential participants should be informed in the written informed consent form about the consequences of this. Sarko Kwabean is a junior physician at the most prestigious university hospital in the capital. He has been approached by a large pharmaceutical company to be an investigator in a multinational osteoporosis clinical trial. Kwabean has accepted the offer, and on the upcoming Friday, he will fly to Johannesburg, South Africa, for an investigators’ meeting. Kwabean puts up his hand and asks, Why should we sign a conflict-of interest form? You see, a conflict of interest form is seen as an essential trial document, since we must ensure that we have no conflicts that may distort the data that we will collect during the course of the trial. Comments to Essential Trial Documents Scenario 1 the Faculty of Medicine Board has its monthly meeting the next day, after Dr. Kwabean has returned from Johannesburg, and this is the first board meeting he has attended.

These programmes maintained a record of cases receiving prophylaxis purchase samsca 15 mg, but did not have a role in coordinating the provision of prophylaxis buy discount samsca 15mg on-line. The register is used both as a surveillance register and a tool to purchase samsca overnight generate dental referrals and delegated authority prescriptions to aid penicillin delivery by the district nursing service. Those who miss their prophylaxis are actively sought for three to six months before being inactivated on the register. Community nurses from other areas can also refer confirmed cases to the register for ongoing prophylaxis. In the Auckland register review by Spinetto et al patients originating from outside Auckland were found to be at risk. A recent study by paediatrician Dr John Malcolm and colleagues in the Bay of Plenty found that non-compliance was a risk factor for multiple poor health outcomes. This person should have skills in data management, basic epidemiology, and clinical medicine, or ready access to clinical expertise when individual case management issues arise. To ensure that the programme continues to function well despite staffing changes, activities must be integrated into the established health system. Every effort should be made to utilise community contacts in the area, and a period on hold with continued attempts to contact, should be used prior to considering discharge. In Auckland early discharge off prophylaxis due to persistent non-adherence, is rare. A protocol for the management of non-adherent patients can be found in Appendix H. Progressive dilation results in myocardial fibrosis and eventually ventricular dysfunction and cardiac failure. Mitral valve pathology evolves over many years after the acute inflammation has resolved, with fibrosis of the valve leaflets and subvalvular structures. The valve leaflets become immobile leading to mixed mitral regurgitation and stenosis. The individual lesions of mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis (a rare scenario), tricuspid regurgitation and multi-valvular disease have their own specific pathogenesis, symptoms, and signs. Serial echocardiographic data plays a critical role in determining the timing of any surgical intervention and balloon mitral valvuloplasty. Cardiologists have a key role to reinforce the need for secondary prophylaxis for their patients. This schedule may be tailored to the needs of the individual and may also differ depending on local resources. All patients should receive education about oral hygiene, and should be referred promptly for dental assessment and treatment when required. This is especially important prior to valvular surgery, when all oral/dental pathology should be investigated and treated accordingly (Grade D). It is recommended that all patients with rheumatic heart disease (regardless of severity) undergo at least annual oral health review. The effectiveness of additional antibiotic prophylaxis prior to dental procedures is controversial, however antibiotic prophylaxis is recommended for at risk patients having at risk dental procedures. Current New Zealand Heart Foundation148 recommendations for antibiotic prophylaxis for dental procedures are detailed below: Patients Requiring Antibiotic Prophylaxis Patients with the following conditions require antibiotic prophylaxis have been selected because of a high lifetime risk of endocarditis and a high risk of mortality or major morbidity resulting from infective endocarditis, should it occur. Prophylaxis is recommended for people with rheumatic valvular heart disease but is not recommended for those who have had previous rheumatic fever without cardiac involvement on echocardiogram. Of note: Prophylaxis is recommended only for people with rheumatic valvular heart disease and is not recommended for those who have had previous rheumatic fever without cardiac involvement. Dental Procedures Requiring Antibiotic Prophylaxis Prophylaxis is recommended for all dental procedures that involve manipulation of gingival tissue or the periapical region of teeth for instances fillings that extend to or below the gum margin, cleaning teeth at or below the gingival margin and the earlier stages of a root filling when the length of the canal is still being measured. While they are not the only organisms that cause bacteraemia following these procedures, they are the organisms most likely to cause endocarditis.

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Bo agrees to buy discount samsca on-line act as the investigator and starts to buy samsca uk draft the informed consent form purchase samsca 15mg free shipping. This fee corresponds to the fee for the surgery that you have to pay even if you choose not to participate in the study but instead have a normal non-trial associated operation. Elisabeth Crown has just graduated from medical school and has taken up a residential post at the same university hospital. Crown in an investigator-initiated clinical trial harvesting bone marrow from healthy volunteers. Crown is not that keen because she is not familiar with the procedures involved in taking bone marrow biopsies, and is in fact more interested in conducting research in the elderly. Still, she finds it difficult to refuse the invitation, so she replies: Of course. We have no funding, and the hospital will not be able to cover any costs for sideeffects that may occur during the biopsy. Also, ensure participants are informed they will not be able to claim any property rights over their harvested cells, since we will certainly file a patent ourselves. Crown has no experience at all in writing an informed consent form, but is much too proud to let anyone know about her lack of knowledge. So she writes up the informed consent form, including the following two sentences: I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. By giving consent to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples Chapter 4. Comments to Informed Consent Process Scenario 1 Can participants be charged a fee during the course of a trial? This fee corresponds to the surgery you have to pay even if you choose not to participate in the study, but instead have a normal non-study-associated operation. In this scenario, the participant will be charged exactly the same amount for the surgery as for standard care. However, there will be no fee charged for the test snoring device, while there is such a charge when the surgery is performed within the framework of standard care. The charging arrangement seems to be reasonable since it has clearly been declared upfront in the informed consent form and the patient has a choice of participation. However, charging for the test snoring device would not be regarded as ethically sound by many, since it is still a test article that has yet to be proven safe and effective and is provided free of charge by the sponsor. Comments to Informed Consent Process Scenario 2 Can the informed consent text be improved? Crown, a residential doctor, to be a coinvestigator in an investigator-initiated trial related to bone marrow harvesting. She writes up the informed consent form, including the following two sentences as implied by Professor Boss: I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. By giving consent to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the research. The consent should not contain any language that causes the participant to waive any legal rights, or release the investigator, institution or sponsor from liability for negligence. It could be better worded as: ‘This hospital is not able to offer financial compensation or absorb the costs of medical treatment should you be injured as a result of participating in this research. Tissue obtained from you in this research may be used to establish a cell line that could be patented and licensed by the university. Vulnerable Participants Scenario 1 the knock on the door was loud and demanding. Markantonis replied: It might be a bit difficult persuading the mothers to allow their infants to participate, but I have an excellent research nurse who has a lot of experience in these types of studies.

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People tend to purchase samsca 15mg on line make do with what they already know — or at least know about (Weiss purchase samsca 15 mg online, 1986 buy samsca 15 mg online, 276). S C I E N T I F I C R E S E A R C H A N D E V I D E N C E B A S E D P R A C T I C E 29 There has been some skepticism about the promotion of evidencebased policy simply as an extension of evidence-based medicine, that is, policy making is qualitatively different. By citing the above quotation, we do not wish to imply that we should view the decision-making tasks of educational practitioners as similar to those of public health physicians. Rather, we are simply suggesting that decision making among many educational practitioners could also be qualitatively different given the bullet list presented immediately above. Problems with applying research evidence to policy the study just cited goes on to reference an editorial by Black (2001). In this editorial Black notes that a useful distinction has been made between practice policies (use of resources by practitioners), service policies (resource allocation, pattern of services), and governance policies (organizational and finance structures). The linear, rationalist model holds up well, although it shows signs of strain in two areas. Policymakers have goals other than clinical effectiveness (social, financial, strategic development of service, terms and conditions of employees, electoral) 2. Research evidence is dismissed as irrelevant (from different sector or specialty, practice depends on tacit knowledge, not applicable locally) 3. Lack of consensus about research evidence (complexity of evidence, scientific controversy, different interpretations) 4. Other types of competing evidence (personal experience, local information, eminent colleagues’ opinions, medicolegal reports) 5. Poor quality of knowledge purveyors S C I E N T I F I C R E S E A R C H A N D E V I D E N C E B A S E D P R A C T I C E 30 Regarding governance policies, Black notes that the direct influence of research on governance policies has been negligible. He states: Clearly, research has only a limited role because governance policies are driven by ideology, value judgments, financial stringency, economic theory, political expediency, and intellectual fashion. It would be naïve and unrealistic to expect research to provide evidence to clinch arguments about governance policies. Firstly, research has little direct influence on service and governance policy if we adopt criteria set and accepted by researchers. Secondly, the relation between research and policy depends on the arena and, thus, the policymakers. Research evidence is more influential in central policy than local policy, where policymaking is marked by negotiation and uncertainty. Thirdly, the use of research depends on the degree of consensus on the policy goal. They have a poor understanding of how policy is made and have unrealistic expectations about what research can achieve. And fifthly, policymaking is not an event but is ethereal, diffuse, haphazard and somewhat volatile. Black then describes the enlightenment model (Weiss, 1977), where research is seen as but one of several knowledge sources. In the Weiss model research can provide policymakers with new ways of conceptualizing the world, formulating policy issues, mapping the decision making terrain, or challenging conventional assumptions. Black goes on to note that: During the 1980s and 1990s this view was extended to a more interactive model based on a close dialogue between researchers and policymakers in which knowledge is considered to be inherently contestable. Researchers have to accept that their work may be ignored because policymakers have to take the full complexity of any situation into account.

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