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Unless physicians accept the need to change workflow and clini- cal processes and for improved communications within the clinical team buy levitra professional 20 mg overnight delivery erectile dysfunction blogs forums, those changes simply will not occur purchase 20 mg levitra professional mastercard erectile dysfunction remedies pump. Moreover, physician skepticism about the need for change will infect the rest of the clinical team and engender resistance by nursing personnel and others on whom physicians depend for support. Physicians are also going to need to accept hospital help with digitizing their clinical operations in their offices and harmonizing them with the hospitals’ clinical systems. This is likely to be a tall Making an Effective Digital Transformation 173 order in many places, where an unfortunate legacy of the 1990s has been heightened mistrust between physicians and hospital man- agers. In the 1980s and early 1990s, physicians actively resisted any effort by the hospital to reach out to the physician’s office with connectivity strategies, such as remote order entry and retrieval of test results. Many physicians felt that hospitals would be tracking their clinical activities and using the information they generated to control physician behavior. Physicians feared information system linkages to the hospital would be used to profile physicians who practiced “expensive” medicine and enable the hospital to practice so-called “economic credentialing” (e. Rather than converting hospital records first, it encouraged all of the physicians in the community to stan- dardize their office clinical systems on a common platform. Then the hospital made it possible for physicians to connect to and edit their office records through dial-up connections inside the hospital, postponing the conversion of the hospital’s record systems until physicians had become “addicted” to a more convenient electronic practice styles. Suspicion of hospital motives linger, and these must be alleviated if a truly safe patient care environment is to be created. Just as hos- pitals must convince patients and their families that their electronic clinical records will be protected and used judiciously and only by those who need to be involved directly in the care process, so too must hospitals convince physicians that an integrated record plat- form will be used in a way that preserves the privacy and integrity of the physician’s practice. If physicians make it clear to hospitals that they need to make it easier for them to practice medicine, hospital managers and boards will respond. All too often, physicians have used their power to stop the hospital from doing things to change the status quo. The cumulative impact of managed care payment reductions and Medicare spending caps from the Balanced Budget Act of 1997 dec- imated hospital operating margins and cash flows. Hospital credit deteriorated, and many hospitals responded by reducing staff and curtailing capital spending. At the same time, stress and poorly organized workflow contin- ued driving away skilled hospital workers. As of this writing, many hospitals have critical shortages of nurses, pharmacists, radiology technicians, and a host of other skilled professional workers. Many hospital executives have not connected the present scarcity of skilled workers to the systemic problem of a stressful and desolating work environment. Making an Effective Digital Transformation 175 Hospital professionals enter the field to help other people, to take care of the sick and dying. They do not enter the field to drown in a sea of paperwork, boring meetings, and unreturned telephone calls. Although other factors, such as a perception of a loss of control over their work environment and lack of respect by physicians and management, certainly play a role, the catastrophic state of information systems in hospitals has contributed materially to the stress and lack of work satisfaction of the hospital work- force. Traditionally, in hospitals, the ratio has been far lower—10 to 20 percent is more typical. After installation, which will remain a capital expense, much of the complexity and cost of operation will be borne by the vendor or an outsourcing partner and managed much more efficiently in a central location. Internet connectivity is also going to make com- plex healthcare computing more accessible to smaller hospitals and physician clinic settings. Furthermore, they are politically hamstrung by the hospital’s frag- mented department structure. They are often the only “lobby” in the hospital’s management structure for standardization and ease of information flow between departments. Business process outsourc- ing (as opposed to outsourcing food service, for example) is a reliable means that high-technology industries have used to achieve rapid change in manufacturing, supplier, and customer relationships. The business office, including billing and collections, human resources, and ma- terials management are also major functions amenable to outsourc- ing solutions. The contract should also specify functional and economic “end points” that the vendor is expected to achieve, and it should pro- vide financial incentives for achieving them, as well as penalties for failing to achieve them. Outsourcing does not mean surrendering accountability for achieving a more efficient, safer hospital. It is, fundamentally, a partnership through which the hospital acquires skills, knowledge, and personnel from outside the organization to accomplish a complex task. Information technology ven- dors have consistently misrepresented their current capabilities to impress investor analysts and institutional investors who buy or recommend their stock. Vendors often demonstrate products at professional meetings that exist only on PowerPoint slides, with real code and function to follow. Gullible hospital executives who want to be on the cutting edge, but who have not done enough homework to understand how mature a technology is or whether a vendor can actually deliver when they saw in the PowerPoint slides, feel ill-used. Hospital and health system executives need to assume a portion of the blame for what has been historically a very troubled relationship. Instead of signing speculative contracts based on unproven technology, hospi- tal executives should simply say, “Take me to a facility where your 178 Digital Medicine product is actually running. When the management team arrives at the demonstration site, its mem- bers should fan out into the patient floors, clinics, and operating suites and start asking the users, including patients, nursing staff, and physicians, how well the product is working. This is not to say that hospitals should not be willing to experi- ment with vendors and serve as alpha test sites for new technologies. The willingness to take some risks to explore promising applications is vital if the field is to advance technically. Managers should sim- ply enter into alpha-type relationships with eyes open, knowing that they are engaged in an experiment, not the installation of a proven product. The project should be tested in a venturesome, well- managed corner of the hospital or system and ramped up rapidly in the rest of the organization if it works. As a general rule, hospitals should pay vendors based on project completion milestones, with both incentives for rapid and effec- tive installation and penalties for missed deadlines and budgets. If savings in reduced staff are to be achieved, project completion pay- ments should be conditioned upon actually achieving the savings. Managing the change process in the hospital’s clinical and sup- port departments is not something that can be delegated to the vendor. Being willing to provide leadership and to not tolerate bureaucratic excuses and political gamesmanship from inside the organization is critical to ensuring a timely and effective conversion. The risk/reward relationship for innovation in hospital management has been adverse to the innovators. Board members in the largely not-for-profit hospital system hold assets in trust for the benefit of the whole community. Earlier, it was suggested that the reason why enterprise comput- ing in healthcare has been such a challenge is that, in reality, many healthcare organizations are not enterprises at all. This is because individual professions or professionals have retained the power to veto or delay important organizational changes that could benefit patients and the institution as a whole.

The training of those people who will contribute most to society requires an increase in E government funding in university education discount levitra professional 20mg with amex best male erectile dysfunction pills. These trees benefit from coastal fog which is captured by the trees buy generic levitra professional on line top erectile dysfunction pills, causing water to drip onto the soil and therefore watering them. Since fog is now 30 percent less frequent than it was 50 years ago the trees will not have this source of water and are therefore likely to begin to die out. The extreme weather last winter was caused by cold air from the Arctic which is normally kept there by strong winds around the pole. A Other regions of the Northern Hemisphere were hotter last winter than in previous years. Although the weather was very cold last winter, the winter before was of average B temperature. The claims that theories of global warming are incorrect are supported by further C evidence. All the people claiming that theories of global warming are incorrect come from areas D that had very cold weather last winter. Some of the people claiming that the theories of global warming are incorrect do not E come from areas that had very cold weather last winter. As two thirds of adults and a third of children are already obese or overweight, with serious risk of heart disease, diabetes and cancer, the need for proper labelling to warn people about the calorie content of these items is urgent. Which one of the following, if true, most strengthens the argument in the passage above? A Trials show that consumers alter their eating habits when food is calorie-labelled. Many people think that the food and drink consumed at the cinema is as important to the D visit as the film. People who are overweight are sometimes more concerned with their looks than the long E term health risks. Additionally, the availability of more formats means that there is more potential for copies of works to be shared with other fans, who do not pay for them. These fans do not show up in the ratings, so the official ratings do not reflect the relative popularity of a work. A The sharing of works with other fans is more widespread for certain types of music. C The calculation of ratings based on downloads and sales together is not difficult. D Artists are not interested in the popularity of their work, just the sales figures. There is a need to save energy usage in all public services and it is time that the government considered turning off street lighting. Modern cars have powerful headlights which provide a clear view of the road ahead even without overhead lighting. There is also evidence to suggest that when drivers move from an area with lighting to an area without they are more likely to have an accident than those drivers who have driven exclusively on roads without lighting. D Research suggests that older drivers find driving without lighting more difficult. There is evidence that there are fewer daytime accidents on those motorways without E lighting. The grey squirrel, a small, tree-dwelling rodent introduced to Britain over a century ago, is breeding so rapidly that the native red squirrel is disappearing. Encouraging the consumption of the grey species as food may help protect the red one, in her view. However, we can challenge this, as it is all just a cheap publicity stunt to increase business in the restaurant. Which one of the following is the best statement of the flaw in the above argument? D It assumes the disappearance of the red squirrel justifies eating the grey squirrel. They need a stable environment and clean water, uncontaminated by perfume or lotions. There should be a complete ban on this type of pedicure, or else there will soon be no garra rufa. Which one of the following is the best statement of the flaw in the above argument? Badgers are animals believed to be responsible for the spread of bovine tuberculosis which results in large numbers of cows having to be destroyed every year. Animal rights supporters have criticised the proposal, but it is clear that the lives of more cattle can be saved by destroying a smaller number of badgers. Which one of the following is the best statement of the flaw in the above argument? It assumes that the arguments from the animal rights supporters are about the number of A deaths. It assumes that the animal rights supporters believe that badgers have a greater right to B life than cows. It assumes that the animal rights supporters believe that animals that are living freely C have a greater right to life than those that are being bred on farms. However, some observers report that the real number of accidents may be much higher than is shown in the official records as many accidents are not reported by drivers. They also say that during the time when accident figures have decreased, the number of people going to hospitals because of road accidents has stayed constant. Positive views about continually improving road safety may not be supported by what A actually happens. B Government programmes have been unsuccessful in reducing the number of accidents. Hospital admissions are a good way of measuring changes in the number of accidents C on our roads. Biology 41 The following organelles are involved in processing amino acids into glycoprotein: 1. A ii and v B ii and iv C i and iii D iii and v E i and iv 46 Which one of the following molecules will contain the greatest number of different elements? Which one of the following pairs of elements is most likely to form a covalent bond? A first = slightly exothermic; second = very endothermic B first = slightly exothermic; second = very exothermic C first = slightly endothermic; second = very exothermic D first = slightly endothermic; second = very endothermic E first = very exothermic; second = very exothermic 64 In the following reactions, which substances are acting as oxidising agents? A 3 only B 1 only C 2 only D 2 and 3 only E none 66 What is the total number of electrons in the ions of sodium chloride? Amines Amides Row 1 Ethanoic acid reacts does not react Row 2 Nitrous acid reacts reacts Row 3 Sulphuric acid does not react hydrolyses A Rows 1 and 2 B None of the rows C Rows 1 and 3 D Rows 2 and 3 E All of the rows 68 Consider the following reactions. Physics and Mathematics 70 In a group of students, exactly 2 are male and exactly 1 study mathematics. The probability that a 5 3 male student chosen at random from the group studies mathematics is p. The transformation R is a rotation about the origin and maps A to B, B to C, C to D, etc.

In the face of confinement and limited activity physical condition rapidly decays levitra professional 20 mg online erectile dysfunction age 75. If it is at all possible give some consideration to the value of storing small items of exercise equipment such as a mini-tramp or some sort of stepping device to provide the ability to undertake some form of aerobic or cardiovascular exercise cheap 20 mg levitra professional with visa erectile dysfunction treatment lloyds pharmacy. One possible option is using an exercise bike to run an alternator producing electricity to charge batteries or directly powering the shelter ventilation fans. Killing two birds with one stone, serving a very useful survival purpose while providing aerobic exercise. Depending on the physical shape of the shelter other options for aerobic exercise include skipping or sprint starts against resistance (such as a bungy). Anaerobic exercise is much for easier to perform with limited space using free weights, press-ups, and chin-ups, etc. It should be built into the daily timetable as a scheduled activity and should be compulsory. The importance of exercise has to be balanced against the energy expended undertaking it. If you are relying on a very simple food storage programme with only the core staples then you will have problems quickly. If you have stored a broad range of items, and tinned, and bottled foods in addition to dry staples then it will be less of a problem. If you are in the former group as an absolute minimum you should ensure that you have an adequate supply of multivitamin supplements If you are planning long-term shelter living you should give serious thought to developing a system for gardening within your shelter. Hydroponics is the obvious solution and can be relatively easily grown in a shelter type environment, however, it still requires large amounts of light, water, and nutrients to grow. The nutrient value depends on the type of bean used, how long it is allowed to grow, and the - 88 - Survival and Austere Medicine: An Introduction amount of light it is exposed to. The more light and the longer the growth period the more vitamin A and C will be present with peak levels present at 8 days. In uncooked legumes (beans, peas, lentils) an enzyme which blocks the absorption of protein, is present. The Prudent Pantry, A T Hagan, 1999 – no out of print) - 89 - Survival and Austere Medicine: An Introduction Chapter 11 Long-term austere medicine Introduction Most of what is discussed in this book is related to a short to medium term disasters with serious disruption of medical services, but with a view to eventual recovery to a high technological level in the short to median term, certainly within a generation. The above paints a possible scenario for what may happen in a major long term disaster – a complete permanent collapse of society and, with that medical services; no hospitals, no new supplies or medications, no medical schools, and no prospect of a significant degree of technological recovery. Depending on your level of preparedness (or paranoia) possible scenarios include comet strike, massive climate change, global pandemic, or worldwide nuclear war any of which would result in complete disruption of infrastructure, and knowledge, and an inability to recover to today’s modern level. While all the principles discussed in other sections apply to the early stages of these sorts of disasters what happens when things run out for good, or the doctor/medic in your group is getting old, or dies raises a whole series of other issues. In this section we cover some of the main issues about long-term medical care in a primitive / austere environment. It is not a “how-to” chapter but more a discussion of likely scenarios and thoughts about what is possible and what is not. Despite the pessimistic picture painted in the scenario above with planning and thought it is possible to maintain a surprisingly high level of medical care. We are not talking heart transplants and high-level intensive care, but we are talking quality medical care which can manage even if it cannot cure common medical problems. While at first thought it may appear that the loss of modern technology and medication will place medical care back to the dark ages it is important not to forget that the knowledge underpinning modern medicine is still there. While there may be no antibiotics for your dirty wound you still have an understanding of what causes infection, basic hygiene measures, and good basic wound care so while you may not have antibiotics to prevent or treat infection you will still know how to minimise the chance of infection, and optimise healing, and hopefully a knowledge of other substances with antibacterial properties. For this reason it is extremely important that you have a comprehensive medical library to begin with and that there is a priority to preserve the knowledge the books contain. Having several people with detailed medical knowledge initially is ideal but this for many may not be possible. It is important that there is a degree of cross training within the group at least at a basic level. When it is apparent that a - 90 - Survival and Austere Medicine: An Introduction disaster is likely to be prolonged it is vital that you begin to train someone to the same level as yourself; the best way is probably using an apprenticeship model over several years. This was the way the majority of western doctors (Middle Eastern cultures th have had medical schools for the last 1500 years) were taught until the 17 century when the medical schools took over, and apprenticeships were still common up until early last century although they were considered inferior. Unfortunately learning medicine simply from a book is inadequate and having supervised experience in addition to books is the only real way to learn. For this reason if you are considering a long-term collapse ensure that you also have the resources to teach the basics of biological sciences first before moving onto medicine proper. It would be difficult to teach someone the complexities of medicine without a good understanding of the basics. In addition to modern medical knowledge, if you are planning for a multi-generational catastrophe then you need to study medical history. The practice of medicine in the th th 18 and 19 Century provides, in our opinion, what we may realistically expect in terms of a technological level in medicine with our modern knowledge superimposed over the top. Look at how things were done, and with what instruments, what medications where used, and how; what were the medical problems encountered? Much from that time is simply wrong and reflects the ignorance of physiology and pathology of the times but there is much to learn, and when approached with modern knowledge it is easy to identify what is useful information and what is not. An interesting way to appreciate the medical problems of the time is by looking at the causes of death during that period; this gives some insight into likely serious medical problems in this sort of scenario now. Below are some of the commonest causes of th death in early 19 Century in Australia. In addition to showing causes of death they also show some of the limited medical understanding of the time: • Trauma (including drowning and burns) – deaths from drowning and burns appear to have occurred with frightening frequency. There were also a large number of trauma deaths – both as a consequence of (mostly) farming accidents and violence. While covering a number of different diagnosis for the most part it referred to heart failure and commonly followed episodes of severe chest pain although at the time this wasn’t recognised for what it was – a myocardial infarction • Abdominal distemper – this was a syndrome characterised by severe abdominal pain, abdominal rigidity, fevers, and death. A significant number of cases were probably appendicitis although it is likely that pancreatitis, liver disease (from alcohol abuse), and gallbladder infections accounted for a number of cases. Again, more recently the term referred to typhoid fever, prior to this it referred to any dysentery. They divided them into one of three groups: • those conditions that can be treated • those that can be contended with • those that cannot be treated It is simple but surprisingly useful because in an austere situation it gives a framework to classify what you can do for your patients; those you can treat and cure, those that you can palliate or make comfortable (until they die or get better), and those that you can do nothing for or where your intervention is likely to make things worse. You need to convey a realistic expectation to your patients of what you will be able to achieve and this provides a simple framework. Lifestyle/Public health Lifestyle: Prior to any disaster it is worth considering what you can do to improve your own and your group’s health. Prevention of diseases such as heart disease, strokes, and diabetes is much better than attempting to treat them in an austere survival situation. You should ensure that all members of your group have their vaccinations up to date especially tetanus, measles, diphtheria, and polio. Preventive medicine: A large proportion of the disease burden in the past is related to poor public health and preventive medicine. For the most part it was related to ignorance of the role of bacteria in causing disease. Key elements of preventive medicine and infection control include: • Clean drinking water – uncontaminated by sewage and waste water • Hand washing – soap production is a priority.

The taxa symbols appear in the factsheet headers in two colours: black indicates the taxa that are usually affected order 20 mg levitra professional overnight delivery erectile dysfunction treatment in delhi, and grey indicates the taxa that can also be affected (see example above) generic levitra professional 20 mg overnight delivery erectile dysfunction doctors in coimbatore. Taxa symbols Invertebrates Animals without backbones – all animals except fish, amphibians, reptiles, birds and mammals. Fish Unlike groupings such as birds or mammals, ‘fish’ (not a meaningful term for a biological grouping in itself) are not a single clade or class but a group of taxa, including hagfish, lampreys, sharks and rays, ray-finned fish, bony fish, coelacanths and lungfish - any non-tetrapod craniate with gills throughout life and limbs (if present) in the form of fins. Amphibians and reptiles (together known as herpetafauna) Animals from the classes Amphibia (such as frogs, salamanders and caecilians) and Reptilia (such as crocodiles, lizards and turtles). These categories are assigned based on impacts at the global scale rather than impacts on an individual or a population. Impact colours Severe impact Mild impact Moderate impact No impact The and symbols indicate whether or not a disease can occur in the group specified, so for example if the humans box is ticked ( ), the disease is zoonotic (can be transmitted to humans and cause disease); if the box is crossed ( ), the disease does not occur in humans. It should be noted that this symbol may refer to the disease in only some situations, i. Notifiable diseases bring trade restrictions and a range of necessary disease control measures. Trypanosomiasis is considered the most important disease of livestock in Africa where it causes severe economic losses. The disease has the greatest impact on domestic cattle but can also cause serious losses in domestic swine, camels, goats and sheep. Infection of susceptible cattle results in acute or chronic disease which is characterised by intermittent fever, anaemia, occasional diarrhoea and rapid loss of condition and often terminates in death. Although most trypanosomes that cause African animal trypanosomiasis are not known to be zoonotic, some are of zoonotic concern, e. Trypanosoma brucei rhodesiensi and other closely related trypanosomes do infect humans. Non- zoonotic trypanosomes might cause disease in people with certain genetic defects. Causal agent Trypanosomes, protozoan parasites of the genus Trypanosoma that live in the blood, lymph and various tissues of vertebrate hosts. Species affected Many species of domestic and wild animals including cattle, swine, camels, goats and sheep. Cattle are prefered by the tsetse fly and this preference can shield other animals from the effects of trypanosomiasis. Wild animals known to be infected but which are trypanotolerant include greater kudu Tragelaphus strepsiceros, warthog Phacochoerus africanus, bushbuck Tragelaphus scriptus, bush pig Potamochoerus porcus, African buffalo Syncerus caffer, African elephant Loxodonta africana, black rhinoceros Diceros bicornis, lion Panthero leo and leopard Panthera pardus. Geographic distribution Endemic in Africa, primarily occurring in areas inhabited by the tsetse fly. In Africa this falls between latitude 14° N and 29° S - that is from the southern edge of the Sahara desert to Zimbabwe, Angola and Mozambique (‘the tsetse fly belt’) an area of 10 million square miles affecting nearly 40 countries. Despite a century or more of effort to eradicate the tsetse fly, the trypanosomes have persisted across their range except in areas where all vegetation has been removed. The three main species of tsetse flies responsible for transmission are Glossina morsitans, which favours open woodland on savanna; G. Fomites (inanimate objects such as footwear, nets and other equipment) can also mechanically transmit trypanosomes. How is the disease Trypanosomes must first develop within tsetse fly vectors for one to a few transmitted to animals? They are then transmitted through tsetse fly saliva - when flies feed on an animal they inject saliva before sucking blood. Trypanosomes can also be mechanically transmitted by biting flies when these flies transfer blood from one animal to another. How does the disease Tsetse flies or mechanical vectors carrying trypanosomes from one group of spread between groups animals to another. Animals imported from endemic areas can be subclinical carriers and may become ill with the disease when stressed. Recommended action if Contact and seek assistance from appropriate animal health professionals suspected immediately if there is any illness in livestock. Diagnosis The disease should be confirmed by health professionals identifying pathogenic trypanosomes in blood or lymph node smears. Anticoagulated fresh blood, dried thin and/or thick blood smears, and smears of needle lymph node biopsies can be submitted from live animals. Trypanosomes are most likely to be found in the blood by direct examination during the early stages of infection. They are less likely to be detected in chronically ill animals, and are almost never seen in healthy carriers. Xenodiagnosis (looking for the parasite in a previously uninfected vector which is exposed to the host, rather than the host itself) is also a useful technique when attempting to isolate from wildlife. Before collecting or sending any samples from animals with a suspected animal disease, the proper authorities should be contacted. Samples should only be sent under secure conditions and to authorised laboratories to prevent the spread of the disease. Although the trypanosomes that cause African animal trypanosomiasis are not known to be zoonotic, precautions are recommended when handling blood, tissues and infected animals. Various environmental measures can be used to control the vector: Buffer zones: if tsetse fly wetlands occur near villages, a buffer zone, i. Habitat modification/removal: tsetse flies need shady and relatively humid conditions. The distribution and ecology of the different species of tsetse fly are closely linked with vegetation. Any modification in vegetation cover may affect the dynamic behaviour of the tsetse fly populations and the transmission of trypanosomiasis. In extreme circumstances, it may be necessary to remove the tsetse fly habitat however bush clearing can lead to soil erosion and other ecological disruption. Persistent chemicals are no longer used for environmental reasons and other non-persistent forms of spray are applicable in certain, mostly open, habitats e. Control of Vectors Secondary control methods should employ veterinary interventions and reduce the spread of the parasite by using preventative treatments, treating infected animals and monitoring the number of animals that carry the disease. Vaccination There is currently no vaccine against human or animal trypanosomiasis. Some African cattle and small ruminant breeds have some tolerance to trypanosomiasis. Introduction and development of these breeds may be effective in lessening the impact of trypanosomiasis. However it should be noted that: - Immunity may only be local and therefore ineffective against trypanosomes from a different region. Switching from cattle to poultry farming, for example, can allow animal protein production without losses to trypanosomiasis. In mixed wildlife-livestock systems, tsetse can preferentially feed on wildlife species and this has a dilution effect on livestock attack. If an outbreak is detected early, the parasite might be eradicated by: Movement controls and quarantine periods Euthanasia of infected animals - trypanosomes cannot survive for long periods outside the host and disappear quickly from the carcase after death.

New technologies may allow for 372 greater understanding and/or confidence when ensuring product quality 20mg levitra professional fast delivery www.erectile dysfunction treatment. Applicants should 373 periodically evaluate the appropriateness of a product’s analytical methods and consider new or 374 alternative methods buy levitra professional overnight erectile dysfunction levitra. The number should be based on 378 scientific principles and an assessment of risk. For complex products that are sensitive to 379 manufacturing changes, reserve samples can be an important tool to make these comparisons. In some cases, changes to the drug 387 substance or drug product manufacturing process may also warrant analytical procedure 388 revalidation. Analytical method revalidation may also be warranted because 396 of manufacturing process changes, such as an alteration in the drug substance manufacturing 397 process that could impact method performance (e. For information on 409 statistical procedures to use for determining equivalence of two test methods, appropriate 19 410 literature or text should be consulted. You must present evidence “…demonstrating that the 427 modification will provide assurances of the safety, purity, potency, and effectiveness of the 428 biological product equal to or greater than the assurances provided by the method or process 429 specified in the general standards or additional standards for the biological product. You should perform an analytical method comparability study 436 that demonstrates at a minimum that: 437 438 • The new method coupled with any additional control measures is equivalent or 439 superior to the original method for the intended purpose. Analytical Methods Transfer Studies 466 467 Analytical method transfer is typically managed under a transfer protocol that details the 468 parameters to be evaluated in addition to the predetermined acceptance criteria that will be 469 applied to the results. Transfer studies usually involve two or more laboratories or sites 470 (originating lab and receiving labs) executing the preapproved transfer protocol. The comparative studies are performed to 473 evaluate accuracy and precision, especially with regard to assessment of interlaboratory 474 variability. In cases where the transferred analytical procedure is also a stability-indicating 475 method, forced degradation samples or samples containing pertinent product-related impurities 476 should be analyzed at both sites. As draft documents, they are not intended to be implemented until published in final form. Trapp, 2004, Basic and Clinical Biostatistics, 4th edition, Lange 612 Medical Books/McGraw Hill. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3. Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. To submit requests for commercial use and queries on rights and licensing, see http://www. If you wish to reuse material from this work that is attributed to a third party, such as tables, fgures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain per- mission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. Many health systems in low- and middle-income countries are least prepared to manage this burden, and large numbers of cancer patients globally do not have access to timely, high-quality diagnosis or treatment. Cancer, when identifed early, is more likely to respond to effective treat- ment, resulting in a greater probability of surviving as well as less morbid and less expensive treatment. The value of detecting cancer early is clear, and signifcant improve- ments can be made in the lives of cancer patients. There are two distinct strategies that promote early detection, and health planners must understand their difference, relevance to particular cancer types, system requirements and impact to develop the most effective programmes. Early diagnosis identifes symp- tomatic cancer cases at the earliest possible stage compared to screening that seeks asymptomatic cancer or pre-cancerous lesions in a target population without symptoms. Improving early diagnosis capacity is an important strategy to cancer control in all set- tings, strengthening health systems and providing universal health coverage. It is founded on core principles in delivering clinical services that include community empowerment and engagement, improving health literacy, access to primary care, diagnostic capac- ity including pathology, strong referral mechanisms, coordination and accessing timely treatment. Effective cancer care requires that these services are accessible, well coordi- nated and provided without delay. This guide is intended to support programme managers in cancer control by clarifying the concept of early diagnosis and helping users to operationalize early diagnosis pro- grammes. There is no single approach that fts all situations thus necessary adaptations are required. In all countries, the desire to detect cancer early means that governments must address barriers to timely cancer diagnosis and to high-quality cancer care. By identi- fying appropriate strategic investments in cancer control, we can achieve these targets and reduce the burden of cancer globally. The principal writing team consisted of André Ilbawi, Cherian Varghese, Belinda Loring, Ophira Ginsburg and Marilys Corbex. A frst working draft of the report was peer reviewed at a meeting in Geneva, Switzerland, on 2–3 December 2015 with the following participants: Otis Brawley, Nathalie Broutet, Hugo De Vuyst, Ophira Ginsburg, André Ilbawi, Etienne Krug, Khunying Kobchitt Limpaphayom, Anthony Miller, Groesbeck Parham, Paul Pinsky, Cherian Varghese and and the Centers for Disease Control and Prevention Offce of International Cancer Control. Contributions in the form of literature reviews and input came from the International Agency for Research on Cancer and the United States National Cancer Institute. Valuable input in the form of contributions, peer reviews and suggestions was provided by: Benjamin O. Anderson, Shannon Barkley, Partha Basu, Rebekah Thomas Bosco, Ann Chao, Melanie Cowan, Jean-Marie Dangou, Hugo De Vuyst, Gampo Dorji, Tim Eden, Ibtihal Fadhil, Alison Harvey, Deborah Ilaboya, Silvana Luciani, Gemma Lyons, Joyce Nato, Jayasuriya Navaratne, Paul Pinsky, Liang Qu, Kunnambath Ramadas, Leanne Riley, Rengaswamy Sankaranarayanan, Mona Saraiya, Nereo Segnan, Hai Rim Shin, Slim Slama, Lisa Stevens, Richard Sullivan, Julie Torode, Ted Trimble and Adriana Velazquez-Berumen. This guide was developed with fnancial contributions from the United States National Cancer Institute. Approximately two thirds of global cancer deaths are in less developed countries, where case fatality rates are higher due to late-stage presentation and less accessible treatment (1,3). The consequences of delays in care and advanced cancer are dire – the likelihood of death and disability from cancer increases signifcantly as cancer progresses. It is therefore critical to identify barriers to timely diagnosis and treatment and to implement programmes that provide access to care for all (4). The Early detection module describes the two approaches that enable timely diagnosis and treatment of cancer: (i) early diagnosis, that is the recognition of symptomatic cancer in patients; and (ii) screen- ing, which is the identifcation of asymptomatic disease in an apparently healthy target population (5). This guide further explores the importance of early diagnosis in com- prehensive cancer control.

Arabic medicine buy levitra professional with paypal erectile dysfunction treatment penile prosthesis surgery, in turn buy generic levitra professional 20 mg on-line impotence 40 years, was distinct from its early medieval Latin counterpart in its adherence to the philosophical principles of the great- est—or at least the most prolific—physician of antiquity, Galen of Pergamon (ca. Galen, like his predecessor Soranus, was a Greek physician who left his native Asia Minor to seek out a career of medical practice in Rome. When he died in the early third century, Galen left behind a huge body of writings (well over three hundred individual titles). Galen had addressed female physiology and disease inter- mittently in his general writings on physiology and pathology, using, for ex- ample, the female model paradigmatically in his discussion of bloodletting or the nature of the faculties. Galen’s medical writings, though philosophically sophisticated, were not only numerous but too often tedious, long-winded, and obtuse. Greek medical writers and teachers in late antiquity focused on only a handful of Galen’s more concise and cogent works, using them as a basis for teaching in such centers as the school of Alexandria in Egypt. Other writers, such as Oribasius (–), compiled large, synthetic works of medical theory and practice. They drew for Introduction  theseworks on a wide arrayof ancient Greek writers,of whom Galen was given pride of place. With the rise of Islam in the seventh century and the fall of the former Greek territories of Asia Minor and North Africa to the Arabs, Greek medical learning passed to the Arabic-speaking world. Here, Galen’s writings (at least  of which were translated into Arabic) again took precedence and led to newer, even grander synthetic works. These Arabic medical encyclopedias included sections on women’s dis- eases, based in their substance on thework of the Methodist physician Soranus. But their content was stripped of its overlay of Methodist theory, in whose place were substituted Hippocratic and Galenic principles of the workings of the elements (hot, cold, wet, and dry), the humors (blood, phlegm, yellow or red bile, and black bile), the temperaments (the actual elemental or hu- moral predominance that would characterize any given individual), the facul- ties (physiological processes we would today describe in terms of chemical or muscular action), and so forth. Whereas Soranus had argued that the Meth- odist physician need only know the three states—lax, constricted, or mixed— in a Galenic system disease must be distinguished according to which of the four humors predominates in the body (any imbalance in their proper propor- tion being itself a sign of disease). This fusion of Soranus’s nosographies and therapies with Galenic theory resulted in the creation of a Galenic gynecology, which bore the distinctive stamp of its Arab and Muslim creators, not only for the increased philosophical rigidity of the humoral system (which Galen had never been so formal about), but also for the new, unique Arabic contribu- tions to therapy and especially to materia medica (pharmaceutical ingredients). Thus, for example, when the North African writer Ibn al-Jazzār described the various possible causes of menstrual retention, he distinguished between the faculty, the organs, and the substance (of the menses themselves) as the caus- ative agents, dialectically breaking down each of these three categories into their various subcategories. Whereas in modernWestern medical thought menstruation is seen as a mere by-product of the female reproductive cycle, a monthly shedding of the lining of the uterus when no fertilized ovum is implanted in the uterine wall, in Hippocratic and Galenic gynecology menstruation was a necessary purgation, needed to keep the whole female organism healthy. The Hippocratic writers had been incon- sistent on whether women were hotter or colder than men by nature. In Galenic gynecology, in contrast (which in this respect built on the natural philosophical principles of Aristotle), women were without question constitu-  Introduction tionallycolder than men. Men, moreover, were also able to exude those residues of digestion that did remain through sweat or the growth of facial and other bodily hair. Because (it was assumed) women exerted them- selves less in physical labor even while they produced, because of their insuf- ficient heat, a greater proportion of waste matter, they had need of an addi- tional method of purgation. For if women did not rid their bodies of these excess materials, they would continue to accumulate and sooner or later lead to a humoral imbalance—in other words, to disease. When, too, she did not menstruate because of pregnancyor lactation, she was still healthy, for the excess matter—now no longer deemed ‘‘waste’’—either went to nourish the child in utero or was converted into milk. When, however, in a woman who was neither pregnant nor nursing menstrua- tion was abnormal, when it was excessive or, on the other hand, too scanty, or worse, when it stopped altogether, disease was the inevitable result. Nature, in her wisdom, might open up a secondary egress for this waste material; hence Conditions of Women’s suggestion that blood emitted via hemorrhoids, nosebleeds, or sputum could be seen as a menstrual substitute (¶). In mod- ern western medicine, absence of menstruation in a woman of child-bearing age might be attributable to a variety of causes (e. It might not even be deemed to merit therapeutic intervention, unless the woman desired to get pregnant. In Hippocratic and Galenic thought, ab- sence of menstruation—or rather, retention of the menses, for the waste ma- terial was almost always thought to be collecting whether it issued from the body or not—was cause for grave concern, for it meant that one of the major purgative systems of the female body was inoperative. It is for this reason that the largest percentage of prescriptions for women’s diseases in most early medi- eval medical texts (which reflected the Hippocratic tradition only) were aids for provoking the menses. Between the ages of fourteen (‘‘or a little earlier or a little later, depending on how much heat abounds in her’’)84 and thirty-five to sixty Introduction  (upped to sixty-five in the standardized ensemble), a woman should be men- struating regularly if she is to remain healthy. In overall length, the four sections on menstruation (¶¶– on the general physiology and pathology of menstruation, ¶¶– on menstrual retention, ¶¶– on paucity of the menses, and ¶¶– on excess men- struation) constitute more than one-third of the text of the original Conditions of Women. Throughout these long sections on menstruation, the author is adhering closely to his sources: the Viaticum for overall theory and basic therapeutics and the Book on Womanly Matters for supplemental recipes. In ¶, the author tells us that the menses are commonly called ‘‘the flowers’’ because just as trees without their flowers will not bear fruit, so, too, women without their ‘‘flowers’’ will be deprived of off- spring. This reference to ‘‘women’s flowers’’ has no precedent in the Viaticum (the source for the rest of this general discussion on the nature of the menses) nor in any earlier Latin gynecological texts, which refer to the menses solely as menstrua (literally, ‘‘the monthlies’’). Theterm‘‘flower’’(flos) had been used systematically throughout the Trea- tise on the Diseases of Women (the ‘‘rough draft’’ of Conditions of Women, which had employed frequent colloquialisms), and at least fourteen of the twenty- two different vernacular translations of the Trotula (including Dutch, English, French, German, Hebrew, and Italian) employ the equivalent of ‘‘flowers’’ when translating the Latin menses. But just as a tree which lacks viridity is said to be unfruitful, so, too, the woman who does not have the viridity of her flowering at the proper age is called infertile. Menstrual blood is like the flower: it must emerge before the fruit—the baby—can be born. In the Hippocratic writings themselves, although there is discussion of suffocation caused by the womb, the actual term ‘‘uterine suffocation’’ (in Greek, hysterike pnix) is never used. It was only out of loose elements of Hip- pocratic disease concepts (which were always very vaguely defined and iden- tified) that the etiological entity of uterine suffocation was created, probably sometime before the second century . Such movement was thought to be caused by retention of the menses, excessive fatigue, lack of food, lack of (hetero)sexual activity, and dryness or lightness of the womb (particu- larly in older women). When these conditions obtain, the womb ‘‘hits the liver and they go together and strike against the abdomen—for the womb rushes and goes upward towards the moisture. When the womb hits the liver, it produces sudden suffocation as it occupies the breathing passage around the belly. For example, when the womb strikes the liver or abdomen, ‘‘the woman turns up the whites of her eyes and becomes chilled; some women are livid. If the womb lingers near the liver and the abdomen, the woman dies of the suffocation. Multiple means of treat- ment were employed, including the recommendation that, when the womb moves to the hypochondria (the upper abdomen or perhaps the diaphragm), young widows or virgins be urged to marry (and preferably become preg- nant). This was premised, apparently,on the belief that thewombwas capable of sensing odors. Fetid odors (such as pitch, burnt hair, or castoreum) were applied to the nos- trils to repel the womb from the higher places to which it had strayed, while sweet-smelling substances were applied to the genitalia to coax the uterus back into its proper position. Not all the symptoms were listed every time uterine movement was men- tioned by the Hippocratic writers, nor did all cases of pnix involve uterine movement. Whenanattack occurs, sufferers from the disease collapse, show aphonia, labored breathing, a seizure of the senses, clenching of the teeth, stridor, convulsive contraction of the extremities (but sometimes only weakness), upper abdominal distention, retraction of the uterus, swelling of the thorax, bulging of the network of ves- sels of the face. The whole body is cool, covered with perspiration, the pulse stops or is very small. Critical to his views, and to all contemporary criticisms of the ‘‘wandering womb’’ (in- cluding Galen’s, as we shall see in a moment) were the anatomical discover- ies made at Alexandria in the third century .

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