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Future work should look at the effect of rapid healing on cost efficacy, length of hospital stay, and effectiveness, as well as quality of life. Sosnowski is a named inventor of an applicable patent and currently an employee of Pfizer. Other authors were principal investigators and have no financial relationship with Cardium Therapeutic s. W has served as a member of an advisory group for and has received research support and honoraria for speaking from Johnson & Johnson. Placebo GroupIdentical to vehicle component of gel with active drug, however it was saline. The 100 group also showed a significantly decreased time to achieve complete healing vs. Patients followed up to 12 weeks, and given option of crossover treatment if healing did not occur. N = 172 patients with type 1 or 2 diabetes and chronic lower extremity diabetic ulcers. Pvalues not provided and statistics not clear whether there was a significant relationship or not. Reduction of size Follow-up at of ulcer did not 30, 60, 90, 120 show significant and 150 days. Autologous-derived growth factors N=150 with Placebo group Area of ulcer non(n = 51) vs. Placebo tubes water based and did not include active ingredient, twice daily (n = 29). Groups instructed to apply gel twice daily to ulcer for 12 weeks alongside typical wound care. No statistically significant differences reported between varying percentages of talactoferrin gel. Median time to 80% closure of 32 days for 10mg dose, 47 days for 1mg dose, and 57 days for saline control. There was a significantly higher rate of complete ulcer closure in study group compared to control group; 32/46 69. A single application of Graftjacket tissue matrix, plus mineral oil-soaked fluff compression dressing (n = 14) vs. Final ulcer area / depth / volume and number of ulcers healed in favor of Graftjacket, (p 0. There was no significant difference between group A and B for mean change in wound severity score; 14. It is suggested that rebalancing of the wound microenvironme nt by using dressings that inhibit proteases should initiate the repair process and increases the healing potential of autologous growth factors. Reduced debridements and improved phagocytosis were statistically significant, indicating beneficial effects of immunomodulation for ulcer healing. Amgen Austria provided funding for Neumann who assisted in monitoring and analyzing the study. All patients received 4 antibiotics (ceftazidmine, amoxicillin, flucloxacillin, and Results Conclusion Comments N = 37 diabetic patients with moderate sized (diameter 0. N=40 diabetic patients with extensive cellulitis (acute spreading skin infection with involvement of subcutaneou s tissues, characterize d by erythema in association with purulent discharge with or without lymphangitis). Conventional treatment: local treatment (debridement, daily inspection, cleaning with sterile water, disinfection with povidone iodine, surgical removal of necrotic tissues, and occlusive dressing of foot lesions, oral ciprofloxacin 750mg 2x/day plus clindamycin 300mg 4x/day) plus systemic antibiotic therapy (n = 20) vs. Standard treatment: local wound care and parenteral antibiotherapy, ciprofloxacin and metronidazole intravenously (n = 15) vs. Evidence for the Use of Prostacyclin Analogues (Iloprost) There is 1 low-quality in the Appendix. Ulcer improvement rates at 3 months were significantly higher in the Bemiparin group compared to the Placebo group; 26/37 70. Treatment adjunctive to infection treatment, revascularization, off-loading, metabolic control. Tissue Engineered Skin Grafts Apligraf group: There were more Apligraf placed Apligraf patients directly on base who did not a of target ulcer have debridement (n = 40) vs. Shorter with same wound healing primary and time in Apligraf secondary group compared dressings as to control group; apligraf group (p = 0. N= 22 Graftskin group: No statistically patients graft contoured significant diabetes and to ulcer base differences foot ulcer during surgery between groups. Graft skin group 2-weeks in Control: showed complete duration; aggressive healing in 56% of mean age debridement, patients at 12 53. Followadverse events up for 6 months were attributable (weekly first 12 to either weeks). N = 79 patients with diabetic foot ulcer either plantar or dorsal; Mean Age not reported. Keratinocyte group achieved 100% ulcer healing compared to control group (59%) at 12 weeks, p <0. Control Group treated with nonadherent paraffin gauze and scheduled At final follow-up 65. Treatment GroupHyalograft 3D autograft, 2 weeks later, laserskin autograft was applied (n = 80) vs. No significant difference between treatment and control for ulcer healing at 12 weeks; 19 (24%) vs. Complete closure was significantly higher in group A compared to the on Laserskin cannot be differentiated from control techniques. The results permit the suggestion that such bioengineered substitutes are potentially useful in patients with hard-to-heal diabetic dorsal ulcers" Pragmatic, open study. Group Btwo pieces of Dermagraft applied every 2 weeks for a total of 8 pieces and 4 applications (n = 14) vs. Group C: One piece of Dermagraft applied every 2 weeks for a total of 4 pieces (n = 11) vs. Control GroupStandard care with debridement, moist dressings and pressure relief (n = 142) vs. Median time for complete wound closure was 12 weeks in Group A and >12 weeks in the remaining groups. Control groups depicts duration of ulcers 37 weeks longer than in dermagraft group A and 46 weeks longer than group B and 44 weeks longer than group C. Graftskin Group: Graftskin applied after debridement directly over ulcer site and trimmed to fit ulcer. Control Group-Standard care of American Diabetes Association, with complete dressing changes every week, and 2 secondary dressing changes 2x per day (n = 96). Complete wound healing achieved in 63 (56%) of graftskin-treated patients compared with 36 (38%) control patients (p = 0. Median time to complete closure 65 days for graftskin which was significantly lower than 90 days in control group (p = 0. Wound closure between patients treated with Versajet vs conventional debridement (p = 0. Author/Year Sco Sam Compariso Results Study Type re ple n Group (0Size 11) Nursing Assessment Derksen 7. Conclusion Comments "Specialized emergency nurses are able to assess ankle and foot injuries in an accurate manner with regard to the detection of acute fractures after a short, inexpensive course. Evidence for the Use of Education for Ankle Sprain There are no quality studies incorporated into this analysis. Subjects experiencing difficulty with activities at Day 14, 1 month, 3, and 6: p = 0. Suggests longterm benefit in reduction of difficulty with activities (difficulty in walking, running, jogging, forced march) Randomization, allocation methods unclear. Uniform background therapy of 20 minutes cooling, compression and elevation given to all patients using cooled anklet. Withdrawal rates due to adverse events similar in valdecoxib and placebo groups (3. Data suggest no difference in tramadol and placebo at Day 4, with higher withdrawal rates in tramadol group.
- Sliding of one part of the intestine into another, called intussusception
- Obstructive jaundice
- Common choices include doxycycline, amoxicillin, azithromycin, cefuroxime, and ceftriaxone
- Is the pain in the main part of the arm or leg?
- Has it ever happened before?
- Purposefully blink more often. Rest your eyes once in a while.
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Babies are given vitamin K at birth to prevent haemorrhagic disease of the newborn unless parents will not give consent. Breathing and chest wall movementareobserved the head circumferenceismeasuredwithapaper forsignsofrespiratorydistress. Anyintra toraisedintracranialpressure abdominalmasses,whichare andcranialultrasoundshould usuallyrenalinorigin,need beperformedtocheckfor furtherinvestigation. Beforeapproachingthemotherandbaby,theobstetric and neonatal notes must be checked to identify rele vant information. In addition, many congenital anomalies, especially of the heart, presentclinicallyatalaterage. Asmallamountof milkmaybedischarged White vaginal discharge or small withdrawal bleedingirls. It should also be possible to abduct the hipsfully,butthismayberestrictedifthehipisdislo cated. Clinical examination does not identify some infants who have hip dysplasia from lack of develop mentoftheacetabularshelf. Vitamin K therapy Vitamin K deficiency may result in haemorrhagic diseaseofthenewborn. In most affected infants, the haemorrhage is mild,suchasbruising,haematemesisandmelaena,or prolonged bleeding of the umbilical stump or after a circumcision. However, some suffer from intracranial haemorrhage,halfofwhomarepermanentlydisabled ordie. Breast milk is a poor source of vitamin K, whereas infant formula milk has a much higher vitamin K content. Haemorrhagic disease of the newborn may occurininfantswhoarewhollybreastfedbutnotiffed withaninfantformula. Infantsofmotherstakinganti convulsants, which impair the synthesis of vitamin Kdependent clotting factors, are at increased risk of haemorrhagicdisease,bothduringdeliveryandsoon afterbirth. In theearly1990s,onestudysuggestedapossibleasso ciation between vitamin K given intramuscularly and thedevelopment ofcancerin childhood,but this has notbeenfoundinother,muchlargerstudies. Asabsorptionviatheoral routeisvariable,threedosesareneededoverthefirst 4 weeks of life to achieve adequate liver storage. Vitamin K should be given to all newborn infants to prevent haemorrhagic disease of the newborn. If the hip is dislocatable, the femoral head will be pushed posteriorly out of the acetabulum(Fig. Ligamentousclicks withoutanymovementoftheheadoffemurareofno 152 Biochemical screening (Guthrie test) Biochemical screening is performed on every baby. Newborn hearing screening is performed on all infants to detect severe hearing impairment. Screeningforcysticfibrosisisperformedbymeasuring the serum immunoreactive trypsin, which is raised if there is pancreatic duct obstruction. Further reading Lissauer T, Fanaroff A: Neonatology at a Glance, ed 2, Oxford, 2011, Blackwell. If it is anticipated during pregnancy that the infant is likely to require longterm intensive care or surgery, it is preferable for the transfer to the (a) Neonatal mortality by birthweight 800 Neonatal mortality rate <1500g 600 400 200 0 50 55 60 65 70 75 80 85 90 95 00 05 19 19 19 19 19 19 19 19 19 19 20 20 (b) Causes of neonatal deaths Infection 5% Other specific causes 4% Congenital anomaly 23% 1500-1999g 2000-2499g 10 Immaturity 57% Year Figure 10. When a baby requirestransferpostnatally,transportshouldbebyan experienced team of doctors and nurses. Com promised cardiac output diminishes tissue perfusion, causing hypoxicischaemic injury to the brain and other organs. Theneuronaldamagemaybeimmediatefromprimary neuronal death or may be delayed from reperfusion injury causing secondary neuronal death. Although hypoxicischaemic injury usually occurs antenatally or during labour or delivery, it may occur postnatallyorbecausedbyaneonatalcondition. Injuries may also occur during manual manoeuvres, from forceps blades or at Ventouse deliveries. Nerve palsies Brachial nerve palsy results from traction to the bra chial plexus nerve roots. Humerus/femur Usually midshaft, occurring at breech deliveries, or fractureofthehumerusatshoulderdystocia. Surfactantdeficiency is rare at term but may occur in infants of diabetic mothers. Thetermhyalinemembranediseasederives from a proteinaceous exudate seen in the airways on histology. Glucocorticoids, given antenatally to the mother, stimulate fetal surfactant production and are givenifpretermdeliveryisanticipated(seeCh. The rate and severity of problems associated with prematurity decline markedly with increasing gesta tion. Central venous line for parenteral nutrition, if indicated Insertedperipherallywheninfantisstable. Chest X-ray with or without abdominal X-ray Assistsinthediagnosisofrespiratorydisordersandto confirmthepositionofthetrachealtubeandcentral lines. Minimal handling All procedures, especially painful ones, adversely affectoxygenationandthecirculation. Handlingthe infant is kept to a minimum and done as gently, rapidly and efficiently as possible. Parents Although medical and nursing staff are usually fully occupied stabilising the baby, time must be found for parents and immediate relatives to allow them to see and touch their baby and to be kept fully informed. Feeds on demand Loud Makes eye contact, alert wakefulness Responds to sound Breathing Sucking and swallowing Feeding Cry Vision, interaction Hearing Posture Needs respiratory support. Not available for interaction Startles to loud noise Limbs extended, jerky movements (a) (b) Figure 10. Mothergivingher babyexpressedbreast milk(insyringe)via nasogastrictube, allowingcloseeyeand skincontactbetween motherandbaby. Decreased risk Pneumothorax Patent ductus arteriosus Intraventricular haemorrhage Bronchopulmonary dysplasia Mortality 0 0. Treatmentwithraisedambientoxygenis required, which may need to be supplemented with continuous positive airway pressure (delivered via nasal cannulae) or artificial ventilation via a tracheal tube. Highflow humidified oxygen therapy, via nasal cannulae, may be used to wean babiesfromaddedoxygentherapy. Surfactant therapy reduces morbidity and mortality of preterm infants with respiratory distress syndrome.
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You get to know your patients well and strive to restore their mental and physical well-being. You find yourself engaged in challenging and rewarding work: bringing hope to patients suffering from troubling and disabling illness. Kathleen Ang-Lee is a resident in psychiatry at the University of Washington Hospitals. Attitudes toward psychiatry as a prospective career among students entering medical school. Weiss Historically, radiation oncology has been one of the best kept secrets in medicine. Yet the specialty has of late become one of the most competitive fields for entering applicants. Its strength and appeal lies in the multidimensional approach to treating cancer patients. Paradoxically, as popular as the field has become among medical students, radiation oncology remains poorly understood, even by other physicians. Radiation oncologists, who are embedded within the interdisciplinary practice of cancer treatment, play a role as both primary oncologist to cancer patients and as consultants to other physicians. For most physicians, it is easy to think of prescribing a medicinal substance in terms of administering a certain number of milligrams of a drug, delivered perhaps orally or intravenously. Radiation, usually in the form of photons and electrons, works therapeutically on the molecular level by principles similar to other treatment modalities such as chemotherapy. The killing of cells by chemotherapy is induced by chemical substances, while radiotherapy inflicts similar damage through radiation. It is the responsibility of the radiation oncologist to prescribe the proper dose of radiation. Treatment is adjusted accordingly to cause maximum damage to cancer cells while keeping normal tissue within its tolerance. These specialists have a good understanding of how changing the daily dosage or overall length of treatment optimizes these clinical benefits. The difference in susceptibility to radiation between normal cells and cancer cells is called the therapeutic index. A skilled radiation oncologist manipulates each plan to take full advantage of this therapeutic parameter. If you choose to practice radiation oncology, get ready for all manner of button-pushing witticisms. But your more earnest colleagues will often ask you to describe, in the most fundamental terms, what it is that you actually do as this type of doctor. Radiation oncologists do not press buttons any more often than medical oncologists (chemotherapy physicians) stand over a Bunsen burner preparing a concoction of some chemotherapeutic brew. Those who actually deliver the radiation treatment- the therapists-hold their own special position in the care of cancer patients, which is quite separate from that of the physician. For a radiation oncologist, the care of a cancer patient begins with the referral for consultation. Radiation oncologists, therefore, take on the role of consultant, rather than primary, cancer care physician. You will receive patients from another member of the interdisciplinary cancer treatment team. Medical oncologists refer many of their patients with lung cancer or other malignancies to radiation oncologists for further management and specialized expertise. Radiation oncologists rarely receive patients directly from primary care physicians. This is mainly because a patient must first be diagnosed with cancer before they wind up with any oncologist. Sometimes the way to your clinic is even more serpentine, in part because radiation oncology simply remains a bit of a mystery even to other physicians. At the initial consultation, you will perform a history and physical examination that, in keeping with the academic nature of this specialty, is rather inclusive. Any patient under medical care needs observation for sequelae of disease and effects of medical intervention. Because patients receive treatment in clinic every day, the radiation oncologist often diagnoses many medical problems while the patient undergoes treatment. You must be well-versed in Enjoys an intellectual environrelevant surgical procedures, radiment with an emphasis on sciographic images, and pathologic variants entific literature. At consult, radiation oncolo Can cope with treating pagists have a considerable amount of intients who are terminally ill. All radiation oncologists must consider anatomic involvement as defined at surgery and then compare it with findings from diagnostic imaging. Further testing and clinical investigations are an important part of practicing radiation oncology. Radiation oncologists direct the overall plan for their patient by ordering whatever additional diagnostic studies are needed. Comprehensive skill at diagnostic techniques, therefore, serves you well in this specialty. Is that all tumor which needs to be treated, or perhaps there is associated consolidation, which could represent an area of lung that your treatment might spare? For the medical oncologist, this may be less of a consideration if it does not affect their treatment plan. Before initiating any radiation treatment, you may also suspect the presence of metastatic disease. Radiation oncologists need to understand the clinical behavior of the disease so that they can give the most appropriate treatment. Radiation oncologists also require a solid understanding of the histology and pathology of cancer. Endometrial cancer, for example, is one of the common malignancies these physicians treat. For this disease, knowing the pathologic difference between high-grade and low-grade tumors could determine whether a patient should receive any radiation therapy. All of this diagnostic and treatment related information, plus any findings on physical examination, figure prominently in the decision whether to subject a patient to radiation treatment. Just as surgeons think about how they will approach an operation, radiation oncologists synthesize a great deal of information to come up with the best therapeutic regimen. You analyze its relationship to normal and sensitive tissue structures so that they may be protected. Because tissues in the body all have a limit to the lifetime dose of radiation they can safely receive, treatment plans must always take into account this factor. Radiation oncologists incorporate all of these variables as they come up with a treatment plan. Radiation oncologists work side by side with professional dosimetrists, who apply filters and change the relative weights of the beams to meet their specifications. In addition, physicists are also on hand to verify that the plan delivers its dose. Days later (sooner in cases of oncologic-related emergencies like spinal cord compression or superior vena cava syndrome), the patient is on the treatment table, ready to be set up in the same position as at simulation. The therapist aims the collimator (the tube which shapes the beam of radiation as it exits) and takes an x-ray (port film). If the radiation oncologist thinks there is any deviation, the therapist shifts the patient in the appropriate direction. As you can tell, medical students interested in radiation oncology must have a firm grasp of gross anatomy. Radiobiology is the study of the biologic and molecular basis for radiation therapy, such as the cellular response to radiation exposure in differing conditions and time schemes. You will learn how to select different types of radiation, choose appropriate energies, and calculate dose delivered to a patient. It is important not to let a bad experience with physics as a premedical student discourage you from taking a closer look at this specialty.
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Current or history of diagnosis of any form of chronic or recurrent agranulocytosis and/or leukopenia (288. Current diseases of the jaws or associated tissues that prevent normal functioning do not meet the standard. Current severe malocclusion (524), which interferes with normal mastication or requires early and protracted treatment, or a relationship between the mandible and maxilla that prevents satisfactory future prosthodontic replacement does not meet the standard. Current insufficient natural healthy teeth (521) or lack of a serviceable prosthesis that prevents adequate incision and mastication of a normal diet and/or includes complex (multiple fixtures) dental implant systems with associated complications do not meet the standard. Individuals undergoing endodontic care are acceptable for entry in the Delayed Entry Program only if a civilian or military provider provides documentation that active endodontic treatment will be completed prior to being sworn into active duty. Retainer appliances are permissible, provided all active orthodontic treatment has been satisfactorily completed. Individuals undergoing orthodontic care are acceptable for enlistment in the Delayed Entry Program only if a civilian or military orthodontist provides documentation that active orthodontic treatment will be completed prior to being sworn into active duty. Marked external deformity that prevents or interferes with wearing a protective mask or helmet (383. All audiometric tracings or audiometric readings recorded on reports of medical examination or other medical records will be clearly identified. Current hearing threshold level in either ear greater than that described below does not meet the standard: (1) Pure tone at 500, 1000, and 2000 cycles per second for each ear of not more than 30 decibels (dB) on the average, with no individual level greater than 35 dB at those frequencies. Current persistent glycosuria when associated with impaired glucose tolerance (250) or renal tubular defects (271. Current or history of acromegaly, including, but not limited to gigantism or other disorders of pituitary function (253), does not meet the standard. Current nutritional deficiency diseases, including, but not limited to beriberi (265), pellagra (265. Other endocrine or metabolic disorders such as cystic fibrosis (277), porphyria (277. Current joint ranges of motion less than the measurements listed below do not meet the standard. Current joint ranges of motion less than the measurements listed in paragraphs below do not meet the standard. History of surgical correction of knee ligaments does not meet the standard only if symptomatic or unstable (P81. Current joint dislocation if unreduced, or history of recurrent dislocations of any major joint such as shoulder (831), hip (835), elbow (832), knee (836), ankle (837), or instability of any major joint (shoulder (718. History of recurrent instability of the knee or shoulder does not meet the standard. Current devices, including, but not limited to silastic or titanium, implanted to correct orthopedic abnormalities (V43), do not meet the standard. Current or history of contusion of bone or joint; an injury of more than a minor nature that will interfere or prevent performance of military duty, or will require frequent or prolonged treatment without fracture nerve injury, open wound, crush or dislocation, which occurred within the preceding 6 weeks (upper extremity (923), lower extremity (924), ribs and clavicle (922)) does not meet the standard. Current or history of muscular paralysis, contracture, or atrophy (728), if progressive or of sufficient degree to interfere with or prevent satisfactory performance of military duty or if it will require frequent or prolonged treatment, does not meet the standard. Current or history of osteochondromatosis or multiple cartilaginous exostoses (727. Current osteomyelitis (730), or history of recurrent osteomyelitis does not meet the standard. At least two separate refractions at least one month apart, the most recent of which demonstrates more than +/- 0. At least 3 months recovery has not occurred between the last refractive surgery or augmenting procedure and one of the comparison refractions. Current distant visual acuity of any degree that does not correct with spectacle lenses to at least one of the following (367) does not meet the standard: (1) 20/40 in one eye and 20/70 in the other eye. Current near visual acuity (367) of any degree that does not correct to 20/40 in the better eye does not meet the standard. Current complicated cases requiring contact lenses for adequate correction of vision, such as corneal scars (371) and irregular astigmatism (367. Although there is no standard, color vision will be tested because adequate color vision is a prerequisite for entry into many military specialties. Current or history of chronic pelvic pain or unspecified symptoms associated with female genital organs (625. For the purposes of this regulation, confirmation is by colposcopy or repeat cytology. Current or history of chronic scrotal pain or unspecified symptoms associated with male genital organs (608. History of major abnormalities or defects of the genitalia, such as a change of sex (P64. Current cystitis (595), or history of chronic or recurrent cystitis does not meet the standard. Current or history of urolithiasis (592) within the preceding 12 months does not meet the standard. Recurrent calculus, nephrocalcinosis, or bilateral renal calculi at any time, does not meet the standard. Current contraction (723) of the muscles of the neck, spastic or non-spastic, or cicatricial contracture of the neck, to the extent that it interferes with the proper wearing of a uniform or military equipment or is so disfiguring as to interfere with or prevent satisfactory performance of military duty, does not meet the standard. Current or history of all valvular heart diseases, congenital (746) or acquired (394), including those improved by surgery, do not meet the standard. Mitral valve prolapse or bicuspid aortic valve is not disqualifying unless there is associated tachyarrhythmia, mitral regurgitation, aortic stenosis, insufficiency, or cardiomegaly. Current or history of symptomatic arrhythmia or electrocardiographic evidence of arrhythmia. Premature atrial or ventricular contractions sufficiently symptomatic to require treatment, or result in physical or psychological impairment, do not meet the standard. Occasional asymptomatic unifocal premature ventricular contractions are not disqualifying. Current or history of cardiomyopathy (425), including myocarditis (422), or congestive heart failure (428), does not meet the standard. Current or history of pericarditis (420) (acute nonrheumatic), unless the individual is free of all symptoms for 2 years, and has no evidence of cardiac restriction or persistent pericardial effusion, does not meet the standard. Current or history of congenital anomalies of heart and great vessels (746), except for corrected patent ductus arteriosus, do not meet the standard. Current or history of abnormalities of the arteries and blood vessels (447), including, but not limited to aneurysms (442), atherosclerosis (440), or arteritis (446), do not meet the standard. Current or history of hypertensive vascular disease (401) does not meet the standard. Elevated blood pressure defined as the average of three consecutive sitting blood pressure measurements separated by at least 10 minutes, diastolic greater than 90 mmHg or three consecutive systolic pressure measurements greater than 140 mmHg does not meet the standard (796. Current or history of venous diseases, including but not limited to, recurrent thrombophlebitis (451), thrombophlebitis during the preceding year, or any evidence of venous incompetence, such as large or symptomatic varicose veins, edema, or skin ulceration (454), does not meet the standard. Body build the cause for rejection for appointment, enlistment, and induction is deficient muscular development that would interfere with the completion of required training. Current abnormal elevation of the diaphragm, either side, does not meet the standard. Any nonspecific abnormal findings on radiological and other examination of body structure, such as lung field (793. Current or history of acute infectious processes of the lung, including but not limited to viral pneumonia (480), pneumococcal pneumonia (481), bacterial pneumonia (482), pneumonia other specified (483), pneumonia infectious disease classified elsewhere (484), bronchopneumonia organism unspecified (485), pneumonia organism unspecified (486), do not meet the standard until cured. Asthma (493), including reactive airway disease, exercise-induced bronchospasm or asthmatic bronchitis, reliably diagnosed and symptomatic after the 13th birthday, does not meet the standard. Reliable diagnostic criteria may include any of the following elements: substantiated history of cough, wheeze, chest tightness, and/or dyspnea that persists or recurs over a prolonged period of time, generally more than 12 months. Current bronchitis (490), acute or chronic, symptoms over 3 months occurring at least twice a year (491), does not meet the standard. Current or history of bronchopleural fistula (510) unless resolved with no sequelae does not meet the standard.
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Food safety management is beset by a lack of data, so writing a wish list of all the data one would like will inevitably lead to disappointment. Other approaches, such as building simplified model-based reasoning to describe the system or process before considering the data availability, have been proposed as preliminary activities to aid in determining the form of the risk assessment. Data that has not previously been seen to be important often arises in contamination studies with infrequent positive data. Such data are not usually valuable for scientific journals; therefore researchers have less interest in conducting such studies. Using the risk assessment framework, it may be possible to determine which gaps have the most influence on being able to address the risk management questions. This identification process can be used to set priorities for future data collection and experimental research. Problems here include, for example, decisions on identification and selection of experts, the number of experts required, techniques for eliciting information, overcoming bias, etc. When expert opinion is required, the problems and methods of selection, overcoming bias, etc. Techniques like the Delphi method (Linstone and Turoff, 1975), which aim to achieve consensus among a panel of experts, can help produce more reliable estimates from the available information. However, there are situations when there truly are very few, and on 20 Purpose of microbiological food safety risk assessment occasions perhaps only one, expert in the specific topic worldwide. This leads to the use of inputs with very wide levels of uncertainty, whatever the risk assessment type, which is far from ideal but may on occasion be the only option in the short term. In a quantitative risk assessment, it is necessary to convert expert opinion into a numerical input, and once again various methods exist and are being actively developed (see, for example, Gallagher et al. Even in a qualitative risk assessment, these methods may also be used to convert expert opinion into numerical values for specific model steps, and this is, where time allows, the preferred method. As noted earlier, when used to describe approaches to risk assessment, the terms quantitative or qualitative do not refer to formally defined categories of risk assessment. An alternative and less sophisticated way of using expert opinion in qualitative risk assessments, however, may be to ask directly for an opinion on the probability of a specific step in narrative terms of, for example, high, low, negligible, etc. In principle, such a method should be only a temporary measure until improved data are available. The worst case scenario is usually used to filter out whether a risk or an exposure pathway is worth worrying about. No further analysis is necessary if the most pessimistic estimate shows the risk level to be below some threshold of interest. Conversely, a best-case scenario can be used as a preliminary filter of possible risk management options. Where there is considerable but quantified uncertainty about a model parameter, a value is used that gives the required extreme. This will usually be an extreme value from the uncertainty distribution of the parameter, like its 1st or 99th percentile. However, when there is not a monotonic relationship between the parameter value and the risk estimate (i. Potential problems with worst-case analyses include that the analysis usually focuses on the consequences of the worst case, without the context of the probability of that worst-case scenario occurring, and that it is difficult to specify the conditions that might lead to the worst (or best) case: absolute extremes may be limited only by our imaginations. Conversely, Risk characterization of microbiological hazards in food 21 wherever parameter values or exposure pathways are known with considerable certainty, they should be used to avoid exaggerating the extreme scenario beyond what is feasible. Evaluating best- and worst-case scenarios can be considered as a risk assessment if the information about the extreme probability is credible and sufficient for the decision-maker. Complying with all the requirements of transparency, of describing model and parameter uncertainties, and all the explicit and implicit assumptions, does not necessarily communicate to risk managers the degree of confidence that the risk assessor has in the results of the risk assessment or limitations in its application. Thus, risk assessors must explain the level of confidence they feel should be attached to the risk assessment results. All assumptions should be acknowledged and made explicit in a manner that is meaningful to a non-mathematician. This type of explanation enables the risk manager to better understand the assumptions, and perhaps pose more informed questions about the effect of any violation of the assumptions. The risk characterization should include a description of the strengths and limitations of the assessment along with their impacts on the overall assessment. The risk characterization should also say whether the risk assessment adequately addresses the questions formulated at the outset of the exercise. Chapter 6 provides detailed advice on assuring the quality of risk characterizations and of assessing their robustness and credibility. It should be emphasized that the attributes of good risk assessment, as described in Section 2. Appropriate data must be collected, documented and fully referenced and synthesized in a logical and transparent manner whichever method is employed. The major difference between qualitative and quantitative risk characterization approaches is in the manner in which the information is synthesized and the communication of the conclusions. Despite a number of large and well-publicized quantitative microbiological food safety risk assessment projects recently completed, it is probable that the majority of risk assessments utilized by risk managers and policy-makers in the fields of food safety, health and microbiology are not fully quantitative in the sense described in Chapter 5. Quantitative microbiological risk assessment is a new and specialized field and methods are still being developed, and the expertise and resources to complete them are not widely available. Whatever the reasons, many of them involve perceptions about the process of defensible qualitative risk assessment that, for reasons also mentioned above, are frequently not valid. Data 24 Qualitative risk characterization in risk assessment are required for any type of risk assessment, irrespective of whether qualitative, semiquantitative or quantitative approaches are used. Numerical data are preferred, and a lack of appropriate crucial data will affect all approaches adversely. As data collection and documentation is usually the most time-consuming part of the any risk assessment, and defensible logic is required to synthesize the data into an estimate or conclusion concerning the risk, a qualitative risk assessment will not necessarily be quicker or simpler to complete. In many cases, qualitative and semi-quantitative risk assessments are quicker to complete, and, whilst they require an equal degree of logic and considerable numeracy, they require fewer specialized mathematical and computational resources. A qualitative risk assessment has descriptions of the probability of an unwanted outcome in terms that are by their very nature subjective. It means that it is not necessarily easier either for the risk manager to understand the conclusions obtained from the risk assessment, or to explain them to a third party. Crucial to any formal risk assessment method is transparency, whether to describe how a numerical or a qualitative description of risk was achieved, because this enables users to understand the basis of the assessment, to understand its strengths and limitations, to question or critique the assessment, or provide additional data or knowledge to improve the assessment. Additionally, because all approaches also require specialized medical, microbiological, biological, veterinary, epidemiological and other expertise, the inclusion of information and concepts from such a wide variety of areas of knowledge can make the risk assessment less accessible. Chapter 8 considers ways in which the results of risk assessment can be better communicated to users and stakeholders. Qualitative risk assessment is not, however, simply a literature review or description of all of the available information about a risk issue: it must also arrive at some conclusion about the probabilities of outcomes for a baseline risk and/or any reduction strategies that have been proposed. However, neither organization explains the conditions under which qualitative and quantitative risk assessments are equally valid, and there is debate among risk experts about methods and approaches to be applied for qualitative risk assessment, and criteria for their validity. The World Trade Organization Committee on Sanitary and Phytosanitary Measures notes some advantages of quantitative expressions of risk: ". The same underlying logic applies whether the assessment is quantitative or qualitative. It is sometimes the case that a qualitative risk assessment is undertaken initially, with the intention of following up with a quantitative risk assessment if it is subsequently thought to be necessary or useful. It may be the case that a qualitative assessment provides the risk manager or policy-maker with all the information they require. For example, perhaps the information gathered includes Risk characterization of microbiological hazards in food 25 some piece of evidence that shows that the risk is effectively indistinguishable from zero, and no more need currently be done. Or, conversely, perhaps evidence shows that it is obviously unacceptably large, or that one or more consequences are so unacceptable that safeguards are needed whatever the magnitude. Analogously, qualitative assessments can be used as a first step to quickly explore or implement protective measures where there is expert consensus that such measures would be immediately effective and useful. As such, if there are obvious sources of risk that can be eliminated, one does not need to wait for the results of a full quantitative risk assessment to implement risk management actions. A qualitative risk assessment may also provide the necessary insights into the pathway(s) associated with the risk of concern, but not previously identified, which also allows the risk manager to make decisions or apply safeguards without further quantification. Synthesizing the knowledge of experts and describing some uncertainties permits at least a ranking of relative risks, or separation into risk categories.
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This raises important questions about whether ethical and broader social considerations can be adequately addressed by continued exclusive funding by the private sector. The addition of the public oversight that accompanies federal funding offers substantial advantages. Such advantages include increased research 24 productivity, earlier results from the research, a broader range of participation by academic scientists, increased public understanding and support, and greater possibilities that therapies will be developed with consideration for the public good will. Private sector sponsorship of research certainly does not preclude a degree of oversight or adherence to ethical practices. Their impact would be greatest if they shared their own findings and recommendations with other companies. This could undermine public confidence and raise anxiety about the manner in which stem cell research is proceeding. There are other concerns associated with sole reliance on private sector funding of stem cell research. There is the very real possibility that market forces and perceived investment opportunities by companies will, in the absence of federal funding, exert a disproportionately powerful influence on the development of stem cell research without adequate attention to public priorities. One result could be that the focus of such research will be on diseases likely to lead to profit at the expense of less common but more severe diseases. There is also the possibility that stem cells will become caught up in an expanded marketing of human body parts. In a day when the market for individual genes, or even gene fragments, holds lucrative possibilities,35 great caution should be taken in ceding domain to this area of research to the private sector in the absence of open and widespread public consultation. Intellectual Property Considerations the appropriateness of patenting life forms has been a source of considerable controversy in this country. Until 1980, life forms were considered to be "products of nature" and ineligible for patent protection. In the twenty years since the first biotechnology patents were granted, various critics have claimed that the patenting of living things promotes a reductionist conception of life that removes any distinction between living and non-living things. Some scientists and lawyers have questioned whether these patents promote the Symposium. While just in its infancy, the potential market for gene-specific pharmaceuticals is huge. For a specific example of a patent held on a partial gene sequence for potentially very important diagnostics and drugs, see. Several ethicists have argued that genes and genetically modified organisms should be considered part of the common heritage of all people. Other thinkers and advocates have raised equity issues about the role of patents in impeding development and access to beneficial technologies. Proponents of life patents typically emphasize that the products being patented do not occur in nature, but are isolated and purified forms representing important technological advances. Corporations can, for example, make the stem cell products over which they hold patents available only under a very restrictive material transfer agreement. They can also set the terms, including limitations that reduce access to these cells. Given the promise of stem cell research, it is important to encourage the development of broadly beneficial therapeutic products with widespread access. Government investment in promising areas of research would enable federal agencies and laboratories to hold patents and to exercise them in ways that enhance development and dissemination of stem cell technology. To qualify, a proposed patent must specify a concrete function, service, or purpose. According to the criteria of "nonobviousness" an invention cannot obtain a patent if the differences between its specific subject matter and the prior art are such that "the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains" (35 United States Code, Sec. One way of doing this is to define a strong research exemption that would give third parties access to stem cell products and research tools for research purposes without having to obtain permission from the patent holder. Still another possibility is to require compulsory licensing under limited and clearly defined circumstances. Public Sector Oversight While efforts by the private sector to provide for ethical review of controversial research are to be applauded, for all of the above reasons a clear federal role in funding and oversight would be far superior to a research endeavor left solely to private institutions. While basic laboratory research with personally non-identifiable stem cells does not pose any special ethical or oversight challenges, an elaborate system of review is in place for research involving human subjects. The Federal Common Rule40 governing human subjects research provides for local and federal agency review of research proposals in such circumstances, weighing risks against benefits and requiring informed and voluntary consent. This approach, which relies on existing regulatory authority, is consistent with the one recommended in this report. The program is a useful first step toward achieving Title 45, Code of Federal Regulations, Section 46. Furthermore, it has acquired a degree of legitimacy among scientists in both the public and private sectors, with its Points to Consider45 in the design and conduct of gene therapy research widely accepted. This experience of functioning as a sort of national research ethics committee for gene therapy research protocols from 1984-1994,46 indicates that federal oversight can be effective in fostering rigorous scientific and ethical review and in encouraging public participation in the process. Furthermore, there are some ethical and policy issues that, while not unique to stem cell research. The most obvious one is that it avoids the need to create a new administrative and costly structure when existing mechanisms are in place that could be readily adapted to achieve the objectives of oversight without impeding promising research. This approach balances the promise of scientific innovation with serious consideration of public concerns about a novel technology that manipulates human tissue. It encourages public involvement in national discussions and in deliberations on policy. It permits flexibility through incremental adjustments in guidelines and/or policy in anticipation of or in response to changes in knowledge or technology. It also relies on a system with which researchers in both the private and public sectors and the executive summary is available online: bioethics. Therefore, both the ethical and legal requirements governing research will be familiar to them as they plan and conduct their studies. And it acknowledges the scientific contributions made by the private sector and supports publicprivate partnerships by encouraging the private sector to contribute to the development of ethical guidelines and professional standards for the conduct of stem cell research. The advancement of science has transformed our lives in ways that would have been unpredictable just a half-century ago. Whether stem cell research will have a similar effect remains to be determined, but the promise is so great that it seems wise to consider seriously how best to further such research in a manner that is sensitive to public sensibilities. Public conversations about research and use of human stem cells are well underway. We recognize that science does not exist in isolation from the larger community that feels its effects, whether perceived as good or bad. The work of scientists is, and should be, conditioned and directed by consideration of broader human values. This means that the development of public policy, especially where highly controversial matters are involved, must take all interested sectors of the public into account. It is only through broad-based participation that the values of all stakeholders in the research enterprise can be carefully considered and weighed. Transplant using tissue from a donor individual not genetically identical to the recipient. A constellation of different diseases all characterized by the failure of the body to distinguish "self" from "non-self" causing the body to attack its own tissues. Cultures of disaggregated tissue that can be maintained and propagated for use in research. Some cell lines are immortalized; that is, they can be maintained essentially indefinitely, for one of a variety of reasons. Embryonic stem cells and embryonic germ cells are immortal because they express telomerase, one of the factors necessary for cells to propagate normally. An individual, organ, or part of an organism consisting of tissues of diverse genetic constitution. Research to test the safety and efficacy of new treatments or to compare the effects of different treatments in patients or healthy volunteers. The process of freezing biological materials in such a way that they can be stored for long periods of time, then thawed for use. The outermost of the three primary layers of an embryo; produces the nervous system, the epidermis and epidermal derivatives, and the lining of various body cavities such as the mouth.
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Engineering Stem Cells as a Delivering Vehicle for Gene Therapy Currently, one avenue of gene therapy that is being explored for the treatment of cancer is oncolytic viruses. Specifically, oncolytic viruses are viruses that are engineered to specifically replicate in and kill cancer cells while sparing healthy cells. Due to their tumor-tropic properties, stem cells can carry the gene therapy vectors to tumors and sites of metastases thereby increasing the local concentration of therapeutic at the cancer site while decreasing the required dosage and subsequent side effects. Stem Cell-Based Gene Therapy for the Treatment of Cancer Recently, there has been increasing interest in the development of gene therapies as a unique strategy for the treatment of cancer. Importantly, it was found that both cell sources had similar potential to function as cell carriers. Using these approaches, engineered stem cells are capable of migrating to and continuously producing the drug or enzyme at the sites of cancer and metastases, thus bypassing restrictions such as the short half-life of drugs and the need for repeated drug dosages. In particular, this section will focus on the use of genetically engineered stem cells for: 1) the secretion of therapeutic molecules and 2) the secretion of an enzyme that can then convert a separately administered prodrug. Secretion of Therapeutic Proteins: When genetically engineering stem cells to secrete therapeutic proteins, there are a number of candidate genes including genes encoding proteins that directly act on malignant cells as well as those that affect supporting cells. This is typically achieved using viral methods, as although non-viral vectors have been used and offer some advantages such as lower immunogenicity, they have a much lower efficiency. On the other hand, those that affect supporting cells typically target angiogenesis or induce an immune response via the secretion of interleukins. In particular, this reduction was associated with a significant decrease in angiogenesis (44. Typically, immunotherapies focus on utilizing our own immune systems or its components to attack cancer cells. Moreover, an added benefit of stem cell-mediated prodrug delivery is that the stem cells are eliminated after conversion of the prodrug, thereby abolishing any concern over its long-term fate. G) Relative mean bioluminescent mice pretreated with radiation or dexamethasignal intensities after quantification of in vivo images. Produsing recombinant baculovirus vectors containing the herpes rugs are compounds that are normally nontoxic. E) Representative pictures of brain sections show the tumor size of different groups. Stem Cell-Based Drug Delivery Finally, as mentioned previously, nanoparticle delivery systems are attractive for cancer drug delivery owing to their ability to carry high concentrations of often insoluble chemotherapeutic reagents, while protecting them from degradation by the harsh biological environment. Although seemingly straight forward, as with engineered stem cell therapies, the success of this strategy depends on the ability to load stem cells with nanoparticles without negatively affecting their migration capability and then efficiently release the nanoparticles and drugs once the engineered stem cells have reached the tumor or its metastases. This field of research is still in a nascent stage with the earliest examples of engineering stem cells by loading them with nanoparticle being solely for tracking purposes. Engineering mesenchymal stem cells with silica nanorattle-doxorubicin for glioma therapy. As a result, a significant enhancement in tumor-cell apoptosis and decrease in tumor burden was observed. Lastly, another avenue of research that has engineered stem cells to carry nanoparticles is the use of the delivered nanoparticles for their other functionalities besides drug loading such as hyperthermia or photothermal therapy. Engineering Stem Cells for Other Diseases the development of engineered stem cell therapies for other diseases besides those discussed previously in this Review have primarily focused on autoimmune and other inherited diseases/disorders such as muscular dystrophy, Wiskott-Aldrich Syndrome, and leukodystrophies. In particular, the treatment strategies that have been developed for these diseases fall into two general categories: 1) use of engineered stem cells to deliver genetic material that can correct the inherent genetic defects or 2) engineering the stem cells ex vivo to correct the genetic defect and then reintroducing them back into the patient. Muscular Dystrophy Muscular dystrophy is a group of inherited disorders that are characterized by the degeneration of muscle, which leads to variable degrees of immobility such as confinement to a wheelchair and, in the most severe cases, weakness of the heart and/ or respiratory muscles thereby leading to premature death. As a result, muscular dystrophies are some of the most difficult diseases to treat, as skeletal muscle is composed of large multinucleated fibers whose nuclei cannot divide. To this end, three main therapeutic approaches are currently being pursued: 1) the introduction of genetic material (via viral or non-viral vectors) to repair the genetic mutation, 2) transplantation of dystrophin-positive cells, or 3) modulating the synthesis of endogenous gene products to make up for the mutation. However, significant challenges remain as cell therapies would have to restore proper gene expression in hundreds of millions of postmitotic nuclei. Engineering Stem Cells by Genetic Modification for Muscular Dystrophy A number of studies have demonstrated that genetically engineered stem cells, which express genes that promote differentiation towards a muscle lineage or express the correct form of dystrophin, can be used to treat muscular dystrophy. When transplanted systemically or intramuscularly into cardiotoxin-injured immunodeficient or dystrophic mice, undifferentiated Pax3-induced myogenic progenitors demonstrated considerable potential for skeletal muscle regeneration by differentiating robustly into adult myofibers without the formation of teratomas. Moreover, they can be engineered to express additional functional benefits and have the advantage of avoiding insertional mutagenesis as they do not become integrated into the host cell. Engineering embryonic stem cells with Pax3 to induce differentiation to skeletal muscle for the treatment of muscular dystrophy. B/6 mice (green) also pre-injured with cardiotoxin (both legs) were analyzed as a reference. Moreover, these cells underwent terminal skeletal muscle differentiation as demonstrated by the expression of myosin heavy chain and dystrophin. Finally, morphometric analyses revealed a marked reduction in the fibrotic and cellular infiltrates of treated dystrophic muscles along with reduced necrosis and centrally nucleated muscle fibers indicating that treated muscles underwent fewer degeneration-regeneration cycles. Engineering stem cells to deliver human artificial chromosomes for the treatment of muscular dystrophy. Afterwards, the mice were analyzed for dystrophin expression and morphological and functional recovery (6). Finally, after long-term evaluation of safety, it was found that the use of engineered stem cells did not affect the lifespan of the treated animals. Moreover, platelet counts improved significantly during the first year, although they never returned to normal healthy levels. While serious adverse events did occur in patients 2 and 3 within the first 2 to 6 months of gene therapy, they were mainly due to infection. Clinical trials have also been performed to test retroviral methods for engineering stem cells. Moreover, an increase in platelet count was noted starting 6 to 9 months after gene therapy and stabilized even 2. Lastly, comprehensive insertion-site analysis showed vector integration that targeted multiple genes controlling growth and immunologic responses and despite targeting potential oncogenes, no persistent clonal imbalance had yet been observed at the time of the study. All patients demonstrated significant increases in platelet counts after gene therapy as well as improvements in lymphocyte number and function (Figure 18). However, clonality and insertion site analyses determined that retroviral insertion preferred gene loci within proto-oncogenes, where integration-driven overexpression led to the development of severe side effects such as leukemia. Moreover, cytogenic analysis revealed additional genetic alterations such as chromosomal translocations. However, it is also clear that the method of engineered stem cells is critical to maximize long-term efficacy and genotoxicity. Studies using lentiviral vectors have demonstrated good safety but longterm studies using retroviruses resulted in the development of acute leukemia as well as additional genetic alterations such as chromosomal translocations. Leukodystrophies Lastly, leukodystrophies are a group of genetic diseases that are characterized by white matter deterioration and typically manifest during childhood or adolescence. Overall, most leukodystrophies fall into one of three categories: 1) lysosomsal storage diseases, 2) peroxisomal diseases, and 3) diseases caused by mitochondrial dysfunction. As such, owing to the migratory ability of stem cells as well as their ability to be engineered with various genes, efforts have focused on improving the efficiency of transduction to use these engineered stem cells to replace dysfunctional cells and to deliver the corrected enzyme. However, they were only used to prevent the development of major disease manifestations in mice treated at the presymptomatic stage. For transplantation, a myeloablative busulfan regimen was administered intravenously to the patients in 14 doses over 4 days prior to cell transplantation. Importantly, the disease did not progress in any of the treated patients and analysis of the lentiviral integration demonstrated that there was no evidence of aberrant clonal behavior. The dotted lines indicate (inset, color code) the expected time of disease onset, according to the onset observed in their affected matched siblings; n. Hematopoietic recovery occurred at days 13 to 15 following transplantation and plateaued thereafter. Conclusion In this Review, we discussed the use of engineered stems for various biomedical applications.
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This pathology is characterized by finger palpation pain, mobility restrictions and impact on the function of the affected limb. The objective of the present study was to synthesize and critically analyze information from the scientific literature on conservative interventions (corticosteroid injection, orthoses and sessions of Physical Therapy and Occupational Therapy) or not (percutaneous release and open surgery) in the treatment of stenosing tenosynovitis, presenting the main results and the interventions considered most relevant. Of the 96 studies initially found, seven were selected, which were considered of good methodological quality. According to the time of onset of the condition, conservative and invasive interventions in the treatment of stenosing tenosynovitis are effective and have shown significant gains in the improvement of pain and in the triggering of trigger finger symptoms. However, it was not possible to indicate if one of the interventions stands out from the others. In addition, we found only one study that addressed the treatment using physical therapy. PubMed:(n)=63 "trigger finger", "stenosing tenosynovitis", "physiotherapy", "occupational therapy", "injections", "percutaneous release", "open surgery", "kinesiotherapy" e "exercise".
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Scores can be transferred to a hand function profile sheet matched for age and sex. The items include grip and pinch strength, pegboard dexterity, lacing a shoe and tying a bow, fastening/unfastening 4 buttons, fastening/unfastening 2 safety pins, cutting putty with a knife and fork, manipulating coins into a slot, lifting a tray of tin cans, and pouring a glass of water. Submitted for publication February 11, 2011; accepted in revised form June 7, 2011. Training is necessary as the administrator has to be familiar with setup and administration of items. Content or face validity: items were developed based on a systemic review of other hand function tests. Items were reviewed by 5 occupational therapists who judged the final items to be clear and important unilateral and bilateral tasks. Patients were not involved in development of the test and item-response theory was not used in development or item selection. The majority of hand function tests assess only 1 aspect of function, such as strength or dexterity, and only unilateral tasks, and do not include functional tasks. However, the administrative burden might limit research use for the same reasons listed under clinical usability. The respondent burden might limit research use, although once one is familiar with the test, it can be administered quickly. Pain is assessed at rest and during activities, includ- Hand Function Measures ing gripping, lifting, turning, and squeezing objects, while stiffness refers to morning stiffness upon waking. The function items ask about difficulty turning, fastening, opening, carrying, grabbing, and squeezing various objects (7). There are 15 items divided into 3 subscales: pain (5 items), stiffness (1 item), and function (9 items). Each 1-unit increase for the function subscale was associated with a clinically relevant decrease in hand strength Practical Application How to obtain. Languages available: English, Spanish, French, German, Norwegian, Dutch, and Italian. Items were generated from interactions between experts (health providers) and interviews with patients. Items were retained that had a prevalence of 60% in the sample population and a mean importance rating 2. A higher score indicates greater disability or more difficulty, whereas a lower score indicates less disability or difficulty. Content or face validity was determined by collecting a list of hand activity questions from published indices. Questions that were "never done" by 5% of subjects were eliminated, yielding 18 items (14). Scores on the Cochin Scale were correlated with scores on a visual analog scale for functional handicap (rs 0. Scores on the Cochin Scale were correlated with scores on the Arthritis Hand Function Test (r 0. The purpose of this self-report scale is to measure functional ability in the hand. The questions ask how much difficulty the person has performing 18 tasks without the help of any assistive device. Kitchen tasks include holding a bowl and a plate full of food, pouring liquid, cutting meat, and peeling fruit. The hygiene items include squeezing a tube of toothpaste and holding a toothbrush. Office items include 2 writing tasks, while other items include turning a doorknob, cutting with scissors, and turning a key in a lock. There is a total of 18 items with 5 subscales: kitchen (8 items), dressing (2 items), hygiene (2 items), office (2 items), and other (4 items). Scores on the Cochin Scale correlated with scores on the Revel Functional Index (rs 0. Scores on the Cochin Scale also correlated with other self-reports of hand function, including the Michigan Hand Outcomes Questionnaire (rs 0. Scores on the Cochin Scale were correlated with variables known to have little correlation with disability: age (rs 0. Scores on the Cochin Scale were correlated with variables known to have moderate or little correlation with disability: Richie articular index (rs 0. Scores on the Cochin Scale had little to no correlation with measures of concepts differing from hand function: anxiety (rs 0. The responsiveness of the Cochin Scale after surgery was assessed by testing 52 subjects who were going to have wrist and/or finger surgery 48 hours before the surgery and at least 6 months after surgery. The scale also discriminated between those who improved and those who deteriorated (P 0. The instrument measures hand function, an important element of disease or aspect of life that may be affected by disease. Items probably need to be updated to reflect common hand activities such as keyboarding, texting, and cell phones. It would be nice if scores were interpreted in terms of severity of hand dysfunction. Because the original article did not give the scale a formal name, the scale as also been termed the Duruoz Hand Index and/or Hand Function Disability Scale, which causes some confusion. Psychometric evaluation supports interpretation of scores to make decisions for individuals. Questions ask about using a key, cutting different objects, lifting, buttoning, using tools, writing, and shaking hands. Items are rated on a 4-point scale from 0 (possible without difficulty) to 3 (impossible). The instrument is a quick self-report of hand function often impacted by rheumatic diseases. The measure is appropriate for evaluating interventions but responsiveness may be a concern. Discrepancy in symptoms between 2 hands may make it difficult for patients to score items (13). Responsiveness is not high; psychometric evaluation has not been done with other rheumatic diseases such as rheumatoid arthritis and systemic sclerosis that affect hand function. Putting a sock over 1 hand, putting a paper clip on an envelope, and pouring water from a jug. The instrument measures hand function, an important element of disease or an aspect of life that may be affected by disease. Limited psychometrics; most of the psychometric studies and research using this test have been done by one of the developers of the test. Psychometric evaluation does not appear strong enough to support interpretation of scores to make decisions for individuals. It was designed for children ages 6 years and adults who have impairments in the hand(s). The commercial version has slightly different sizes of equipment than the 1969 publication, which describes a homemade version.
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It is the role of risk characterization to provide to management an unbiased estimate of the level of the risk being considered. If time or the available data are insufficient to carry out a complete quantitative risk assessment, one can use these categorical labels to express the risk level in a more structured way than a simple description of the evidence one has acquired. It is possible to use categorical labels to perform some rudimentary type of probability manipulation. It is only possible to maintain consistency and transparency in combining categorical labelling of elements of a risk assessment if numerical ranges have been defined for each label, and combining categorical labelling nonetheless should still be approached with some considerable caution (see Section 4. Risks 2 and 13, for example, have high severity; risks 3, 5 and 7 have very low severity. A scaling factor, or score, is assigned to each label used to describe each type of impact. If a log scale is used to define each categorical scale, as in the examples provided in Table 4. Severity scores enable the risks to be categorized and ranked according to severity. A key drawback to this approach of ranking risks is that the process is very sensitive to the scaling factors that are assigned to each term describing the risk impacts. However, an analysis may consider other types of impact, like economic loss or erosion of quality of life. P-I tables can be constructed in a number of ways: for example, displaying the various types of impact of each individual risk (such as for a particular bacterium, or a particular food product). Implicit in assigning categories for more than one type of impact is that one has assigned broad correspondence in value between, for example, human health impact and economic loss. The most common approach is simply to take the maximum of the severity scores for the individual impact dimensions. This works reasonably well if the scaling of probability and impact are logarithmic in nature. A slightly more complicated method for getting an overall severity score is to transfer the individual impact severity scores out of logs, add them up, and transfer back into logs. Both of these metrics can be measured for the different impact dimensions (health, cost, etc. More complex metrics can be derived using severity scores, allowing risk exposure to be normalized and compared with a baseline risk. These permit trends in risk exposure to be identified and monitored, giving valuable information to risk managers on the global improvement of food safety, the emerging prominence of any risk, etc. The risks are placed into usually quite broad sets of categories: it is common to use five or so for probability and for impact, not including zero, which gives 25 possible combinations. For example, one could break up the probability range into five categories, as in Table 4. The nature of food safety risk means that we are often dealing with probabilities that span over several orders of magnitude, which also make the use of a log scale more appealing. We cannot easily combine probability scores for components of a risk pathway to get a probability score for the risks as a whole. For example, food safety risk estimation is often split into two parts: the probability of exposure; and the probability of illness given exposure. For example, changing the probability of illness given exposure to anything from 0. The use of a log scale for probability relieves the problem to some extent if we reverse the probability score order described so far to assign the highest probability with the lowest score, as shown in Table 4. This is one reason for having an amber region in the traffic light system, because risks may be over-estimated, and risks falling into an amber region may in fact turn out to be acceptable. The calculation of severity scores would need to be changed with this reversed probability scoring. It changes the range of the severity scores but maintains the same order as in Table 4. For example, for a risk whose probability of occurrence falls just above the boundary between two categories, and for which we have found a risk management strategy that reduces that probability by a small amount, it could be dropped down one probability category, which is now indistinguishable from reducing the probability by a factor of 10. However, there is nothing to stop the risk assessor from using Risk characterization of microbiological hazards in food 45 score fractions if it seems appropriate. The integer system is designed for convenience and simplicity, and should be changed to include fractions if this better represents the available knowledge. Using the semi-quantitative risk assessment scoring system as a surrogate for probability calculations is also likely to cause more severe inaccuracies when one assesses a longer sequence of events. The overview nature of semiquantitative risk assessment also helps one think about more global issues of model uncertainty. That said, quantitative food safety risk assessment results that are not anchored to correspond to observed illness rates frequently span several orders of magnitude of uncertainty. The level of available information may also make it difficult to assign probability and impact categories to a particular risk. One method is to describe the uncertainty by showing a risk as lying within an area of the P-I table, as in Table 4. Graphical shapes, like circles, drawn on the table to represent uncertainty make it easier to plot several risks together. One can also employ standard Monte Carlo simulation to express uncertainty in scores where they are being manipulated in more mathematical analyses discussed above. Variability, such as variability in susceptibility between subpopulations, can easily be incorporated in semi-quantitative risk assessment (where the necessary data are available) by estimating the risk for subpopulations and plotting them separately on the same chart. This provides an excellent overview of how different subpopulations share the food safety risk. The data collected for a qualitative risk assessment are often sufficient for semi-quantitative risk assessment needs. The difference 46 Semi-quantitative risk characterization between the two is that semi-quantitative risk assessment has a greater focus on attempting to evaluate the components of the risk to within defined quantitative bounds. Thus, at times, one may do a statistical analysis on a data set to attempt to more precisely estimate a probability, or the expected impact, providing it will give the assessor more confidence about how to categorize the risk. Semi-quantitative risk assessment is usually used as a means to compare several risks or risk management strategies. At times we may have sufficient data to be able to perform a full quantitative risk assessment for a select number of risks. A quantitative model can give us more information about specific strategies to apply to that particular risk issue, but we can also use the quantitative results to place these more precisely evaluated risks into context with others of concern in a semi-quantitative environment. No sophisticated mathematical model is necessary, for example, which is appealing to the lay person. However, the use of mathematical models as an obstacle to transparency may be overemphasized. Most food safety risk assessments require understanding of complex microbiological information and usually a reasonable level of human medicine, and of epidemiological principles which tend to be postgraduate topics, whereas quantitative risk assessment uses mathematics generally covered at undergraduate level. The main obstacle to transparency of quantitative models is that there are only a few people who have specialized in the field. Semi-quantitative risk assessment encourages the development of decision rules. The framework for placing risks within a P-I table makes it much easier to demonstrate a consistency in handling risks because they are all analysed together. The key transparency issue with semi-quantitative risk assessment arises from the granularity of the scales used in scoring. The usually rather broad categories means that we lose any distinction between risks that can be considerably different in probability and/or impact magnitude. This means, for example, that one food industry could be unfairly penalized because its product lies just above a category, or that industries or regulator only have the incentive to push a risk just over the category boundary. Semi-quantitative risk assessment is a system for sorting out risks, focusing on the big issues, and managing the entire risk portfolio better. The scoring system is inherently imperfect, but so is any other risk evaluation system. If the scoring system being used can be shown to produce important errors in decision logic, then one can use potentially more precise quantitative risk assessment arguments, or change the scoring system to something more precise. The pathogen was selected for assessment because "although it is likely to have minimal public health significance, demonstration of the safety of New Zealand produced food with respect to this pathogen may have trade implications.