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Weight of Mechanistic Evidence the committee assessed the mechanisms by which the vaccine could cause a specifc adverse event by identifying and evaluating clinical and biological evidence. First, the committee searched for evidence in the peer reviewed literature that a vaccine was or may be a cause of an adverse event in one or more persons (from case reports or clinical studies) in a reasonable time period after the vaccination. Chapter 3 contains a discussion of the major mechanisms the committee invokes as possible ex planations of how a given adverse event can occur after vaccination. The committee identifed many case reports in the literature describing adverse events following vaccination. For the purposes of this report, case report refers to a description of an individual patient; one publication could describe multiple case reports. The committee evaluated each case report using a well-established set of criteria called attribution elements for case evaluation (Miller et al. At a minimum, for a case to factor into the weight-of-evidence assessment, it had to include specifc mention of the vaccine administered, evidence of a clinician-diagnosed health outcome, and a specifed and reasonable time interval. Case descriptions that did not have the three basic elements described above were not considered in the mechanistic weight-of-evidence assessments. These three criteria were only necessary but not suffcient to affect the weight of mechanistic evidence. After identi fying cases with the three basic elements, the committee looked for evidence in the case descriptions and in other clinical or biological literature of a possible operative mechanism(s) that would support a judgment that the vaccination was related to the adverse event. See Chapter 3 for a description of possible mechanisms identifed by the committee. An important attribute in the evaluation of the clinical evidence from case reports is rechallenge, an adverse event that occurred after more than one administration of a particular vaccine in the same individual. Each challenge in a patient, however, must meet the same attributes of reasonable latency, documentation of vaccination receipt, and clinician diagnosis of the health outcome. The value of any case report is much greater if the clinical workup eliminated well-accepted alternative explanations for the condition, thus increasing the possibility that the vaccine could be associated with the adverse event. A particularly strong piece of evidence in the case description is laboratory-confrmed isolation of a vaccine strain virus in the patient. Evidence consisting only of parallels with the natural infections is never suffcient to merit a conclusion other than the evidence is inadequate to accept or reject a causal relationship. Evidence from animal studies is also informative if the model of the disease (adverse outcome) is well established as applicable to humans, or if the basic immunology of the vaccine reaction is well under stood. In vitro studies can also be informative, but such data were eyed with skepticism regarding their relationship to the human experience. The committee developed categories for the mechanistic weight-of evidence assessment.
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Although the committee is not aware of reports of full-blown cytokine storm following administration of any of the vaccines reviewed, more subtle imbalances of proinfammatory and anti-infammatory cytokines may occur following immunization against rubella, human papillomavirus, or hepa titis B (Albarran et al. Moreover, it is possible that the unique immunogenetic makeup of an individual might predispose that individual to an exaggerated cytokine imbalance following immune stimulation such as microbial infection or vaccine administration. Superantigens Superantigens are determinants expressed by a microbe that can bypass T cell receptor signaling pathways and directly activate large numbers of T cells. The committee found no evidence that supports superantigen stimulation of immune reactions as an operative mechanism in any of the vaccine adverse events under consideration. Some of these symptoms are attributable to direct or primary infection, persistent viral infection, and viral reactivation. Direct or Primary Infection Primary infection with varicella, for example, results in varicella (chickenpox), manifesting as fever, malaise, listlessness, and a rash consist Copyright National Academy of Sciences. Complications include secondary skin infections, myo carditis, nephritis, pneumonia, central nervous system involvement (acute cerebellar ataxia, encephalitis), and bleeding diatheses (Whitley, 2010). The acute complications of measles infection include otitis media, croup, and pneumonia (Gershon, 2010). Persistent Viral Infection Some viruses are capable of causing permanent, latent infection in nearly all individuals, the herpesviruses and retroviruses being the best known examples. Reactivation, as discussed below, with production of new virus can occur with such latent viruses. With other viruses, some infected individuals are unable to clear the vi ral infection. It is important to note here, however, that the hepatitis B vaccine is not a live virus vaccine and so cannot infect recipients. Viral Reactivation Reactivation of infection can occur when the virus, following the acute infection, remains in a dormant or latent state somewhere in the body, where it can subsequently reemerge. Reactivation results in herpes zoster (shingles), characterized by a unilateral eruption of vesicles with a dermatomal distribution, sometimes accompanied by pain localized to the area (Whitley, 2010). As detailed further below, these effects occur most frequently in patients with impaired immunity. Varicella vaccine virus, which is distinct from the natural varicella virus, for example, has been re covered from the bronchoalveolar lavage fuid and lung biopsy of immuno compromised children who developed pneumonia and rash as a primary infection after receiving a varicella vaccine (Galea et al. As examples of viral reactivation, children who had previously been vaccinated developed zoster and even encephalitis from which vaccine-strain virus was then recovered (Chan et al. Some, but not all, of these children were subsequently shown to be immunocompromised. The salient points in these examples are that the adverse effects observed are complications seen with natural infection and that the causal role of the vaccine virus was demonstrated by its isolation or identifcation by molecular techniques, typically from sites that are otherwise sterile.
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Stimulation of bone healing in new fractures of the tibial shaft using interferential currents. Is Interferential Current Before Pilates Exercises More Effective Than Placebo in Patients With Chronic Nonspecific Low Back Pain Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation Page 21 of 25 UnitedHealthcare Commercial Medical Policy Effective 01/01/2020 Proprietary Information of UnitedHealthcare. Effectiveness of Interferential Current Therapy in the Management of Musculoskeletal Pain: A Systematic Review and Meta-Analysis. A 3-month, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a highly optimized, capacitively coupled, pulsed electrical stimulator in patients with osteoarthritis of the knee. Microcurrent transcutaneous electric nerve stimulation in painful diabetic neuropathy: a randomized placebo-controlled study. Interferential current therapy in patients with knee osteoarthritis: comparison of the effectiveness of different amplitude-modulated frequencies. Dorsal Root Ganglion Stimulation for the Treatment of Complex Regional Pain Syndrome. Neuromuscular electrostimulation for adults with chronic obstructive pulmonary disease. Dose-response relation between neuromuscular electrical stimulation and upper extremity function in patients with stroke. A randomized clinical trial of manipulative therapy and interferential therapy for acute low back pain. Interferential therapy electrode placement technique in acute low back pain: a preliminary investigation. The effects of home interferential therapy on post-operative pain, edema, and range of motion of the knee. Effect of functional electrical stimulation on cardiovascular outcomes in patients with chronic heart failure. Impact of Scrambler Therapy on Pain Management and Quality of Life in Cancer Patients: A Study of Twenty Cases. Contralaterally Controlled Functional Electrical Stimulation Improves Hand Dexterity in Chronic Hemiparesis: A Randomized Trial. Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation Page 22 of 25 UnitedHealthcare Commercial Medical Policy Effective 01/01/2020 Proprietary Information of UnitedHealthcare. Efficacy of microcurrent therapy in the treatment of chronic nonspecific back pain: a pilot study.
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Have the parent or an assistant lay the child on his back in the center of the board with the head touching the fixed headboard, the body straight in line with the board and the shoulders and buttocks flat against the surface. If the child is uncooperative, allow the parent to try to calm the child before trying to re-measure. Measuring Height Equipment Measuring board with tape and moveable headboard or a metal tape attached to a flat wall and a separate headboard (that is a solid right angle). The wall should not have molding or baseboard and the floor should not have a plush carpet. Who to Measure in Standing Position Adults Children who are 24 months and older who are able/willing to stand. Note: Children 2 -3 years who cannot/will not stand and/or measure less than 30 inches and/or weigh less than 20 pounds must be measured in the recumbent position and plotted on the 0 36 month growth chart. Children should have thick socks, shoes, and jackets or any bulky clothing removed. Have the child or adult stand with back against the measuring surface with feet together flat on the floor, arms at side and knees and back straight. When possible, head, heels, buttocks and shoulder blades should touch the measuring surface. With the person looking straight ahead, slide the headboard gently down to the head, compressing the hair. Be sure that the headboard is level and at right angles to the 11 tape and that the heels are still flat against the floor. With your eyes level with the indicator, read the height to the nearest 1/8 inch and jot this figure down. If they do not agree within l/4 inch, repeat the procedure until two measurements agree. Measuring Head Circumference Equipment Flexible, non-stretchable, narrow plastic or paper tape measure. Note: Deviations from the norm in head circumference are usually related to disease, genetic abnormalities, or prenatal nutrition. Position the lower edge of the tape just above the eyebrows and ears, and around the biggest part of the back of the head. Summary of Guidelines for Measuring Stature and Weight Age They should wear Measure to Until agreement nearest within Recumbent Infants/children: light clothing, 1/8 inch 1/4 inch Length 0 to 24 mths. This is not a problem when using an adult beam balance which is already graduated according to lb increments. However, when using an infant beam balance (which reads in ounces) or a digital scale, you must make some conversions. How to convert the ounce readings on an infant beam balance to the nearest lb: Ounces Nearest 1/4 pound 0-2 0/4 3-5 1/4 6-9 1/2 10-13 3/4 14 -15 +1 0/4 (next higher pound) Examples: Weight Converted to nearest 1/4 lb.