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https://medicine.duke.edu/faculty/jennifer-lynn-garst-md

To request the laboratory to insomnia 3dpo cheap 25mg sominex fast delivery provide testing apart sibility of the medical personnel sleep aid use buy cheap sominex 25 mg online, not usually the laboratory sleep aid jokes cheap sominex 25 mg, from the procedure manual places everyone at legal risk insomnia quotes proverbs generic sominex 25mg free shipping. It is the key to accurate laboratory diagbiota changes and etiologic agents are impacted, leading to nosis and confirmation, it directly affects patient care and patient potentially misleading culture results. Susceptibility testing should be done only on clinically signifinfection control, patient length of stay, hospital and laboratory icant isolates, not on all microorganisms recovered in culture. Clinicians and other medical personnel should consult accurate, significant, and clinically relevant. The laboratory should set technical policy; this is not the storage of patient specimens they collect are managed properly. Specimens must be labeled accurately and completely so Throughout the text, there will be caveats that are relevant to spethat interpretation of results will be reliable. Labels such as cific specimens and diagnostic protocols for infectious disease “eye” and “wound” are not helpful to the interpretation of diagnosis. However, there are some strategic tenets of specimen results without more specific site and clinical information management and testing in microbiology that stand as community (eg, dog bite wound right forefinger). Future modifications of the document are to at all times for all medical personnel to review or consult and it be expected, as diagnostic microbiology is a dynamic and rapwould be particularly helpful to encourage the nursing staff to idly changing discipline. Pediatric parameters have been updated review the specimen collection and management portion of the in concordance with Pediatric Clinical Practice Guidelines and manual. Comments and recommendation personnel, who may know very little about microbiology or tions have been integrated into the appropriate sections. When the term “clinician” is used throughout require longer incubation periods; others may require special culthe document, it also includes other licensed, advanced practice ture media or non-culture-based methods. Another unique feature is that in most chapters, there fungi often require special broth media or lysis-centrifugation vials are targeted recommendations and precautions regarding selectfor detection, most Candida spp grow very well in standard blood ing and collecting specimens for analysis for a disease process. Within each chapter, didemia do not yield positive results in almost half of patients. The For most etiologic agents of infective endocarditis, conventest methods in the tables are listed in priority order according to tional blood culture methods will sufce [3–5]. The most common etiologic agents of period, such as 2 hours, it is expected that the sample should culture-negative endocarditis, Bartonella spp and Coxiella burbe refrigerated afer that time unless specifed otherwise in that netii, ofen can be detected by conventional serologic testing. Almost all specimens for virus detection should be However, molecular amplifcation methods may be needed for transported on wet ice and frozen at –80°C if testing is delayed detection of these organisms as well as others (eg, Tropheryma >48 hours, although specimens in viral transport media may be whipplei, Bartonella spp). For adults, 20–30 mL of blood per culture set (depending lizing the microbiology laboratory in infectious disease diagnoon the manufacturer of the instrument) is recommended and may sis. It is a collaborative effort between clinicians and laboratory require >2 culture bottles depending on the system. For neonates experts focusing on optimum use of the laboratory for positive and adolescents, an ageand weightappropriate volume of blood patient outcomes. When the term “recommended” is used in this should be cultured (see Table 3 below for recommended volumes). Infants and children: fi2 As much blood as can be Organisms will usually survive in inoculated culture vials blood culture sets (see conveniently obtained even if not incubated immediately. Malassezia spp reabove) from children; volume quire lipid supplementation; lysis-centrifugation is recomdepends on weight of mended for their recovery. There may be circumstances in which it is prudent to omit the anaerobic vial and split blood specimens between 2 aerobic vials. Such requests should be made in consultation with the microbiology laboratory director. The timing of blood culture orders should be dictated by Skin contaminants in blood culture bottles are common, very patient acuity. In urgent situations, 2 or more blood culture sets costly to the healthcare system, and frequently confusing to clican be obtained sequentially over a short time interval (minnicians. To minimize the risk of contamination of the blood culutes), afer which empiric therapy can be initiated. Recommended Volumes of Blood for Culture in Pediatric Patients (Blood Culture Set May Use Only 1 Bottle) Recommended Volume of Weight of Blood for Culture, mL Patient, Total Patient Total Volume % of Total kg Blood Volume, mL Culture Set No. Consensus guidelines [2] and expert panels [1] • Catheter-drawn blood cultures have a higher risk of contamrecommend peripheral venipuncture as the preferred technique ination (false positives). Two recent studies have documented equivthe anaerobic bottle (faster time to detection). Infections Associated With Vascular Catheters povidone-iodine followed by alcohol is recommended. Laboratories should have policies and procedures for described, the available data do not allow firm conclusions to be abbreviating the workup and reporting of common blood culmade about the relative merits of these various diagnostic techture contaminants (eg, coagulase-negative staphylococci, viriniques [10–12]. Tese procedures may include abbreviated idenof a positive culture from an indwelling catheter segment or tip tifcation of the organism, absence of susceptibility testing, and in the absence of positive blood cultures is unknown. The next a comment that instructs the clinician to contact the laboratory essential diagnostic component is demonstrating that the infecif the culture result is thought to be clinically signifcant and tion is caused by the catheter. This usually requires exclusion of requires additional workup and susceptibility results. Some investigators have Physicians should expect to be called and notifed by the concluded that catheter tip cultures have such poor predictive laboratory every time a blood culture becomes positive since value that they should not be performed [13]. Routine culture of intraveKey points for the laboratory diagnosis of bacteremia/ nous catheter tips at the time of catheter removal has no clinical fungemia: value and should not be done [13]. Although not performed in most laboratories, the methods described include the following: • Volume of blood collected, not timing, is most critical. When a microbiologic diagnosis of less common etiotories): one from catheter or port and one from peripheral logic agents is required, especially when specialized techniques venipuncture obtained at the same time using lysis-centrifuor methods are necessary, consultation with the laboratory gation (Isolator) or pour plate method. In this section, infections are categorized to obtain the correct length (5 cm) of the distal catheter tip. Modifications of the Maki method have been rier into the bloodstream followed by penetration of the blood– described as have methods that utilize vortexing of the catheter brain barrier. Other routes of infection include direct extension tip or an endoluminal brush (not performed routinely in most from a contiguous structure, movement along nerves, or introlaboratories). Infected (Mycotic) Aneurysms and Vascular Grafts fora and should not be sent to the microbiology laboratory Infected (mycotic) aneurysms and infections of vascular grafts for direct smears, culture, or molecular studies. Pericarditis and Myocarditis culture and are required for optimal recovery of mycobacteria Numerous viruses, bacteria, rickettsiae, fungi, and parasites and fungi. When the specimen volume is less than required have been implicated as etiologic agents of pericarditis and for multiple test requests, prioritization of testing must be myocarditis. Whenever possible, specimens for whelming majority of patients with myocarditis, an etiologic culture should be obtained prior to initiation of antimicrobial diagnosis is never made and patients are treated empirically. If anaerobes are suspected, then the culture should consist of an aerobic and anaerobic bacterial culture. If anaerobes are suspected, then the culture should consist of both a routine aerobic and anaerobic culture. Serum should be separated from red cells as soon as from cultures is routinely performed unless contamination possible. This is especially true of sero• Whenever possible, collect specimens prior to initiating antilogic and many molecular diagnostic tests. Continued Transport Issues and Etiologic Agents Diagnostic Procedures Optimum Specimens Optimal Transport Time Other: B. False positives may occur with recent immunization (Japanese encephalitis, yellow fever) or other favivirus infection (dengue, St Louis encephalitis, Zika) [30]. Testing available at the Department of Veterinary Pathobiology, Purdue University (West Lafayette, Indiana), telephone: (765) 494-7558. In patients specifc for parechoviruses is recommended for young children suspected of having bacterial meningitis, at least 2–4 blood cul[29]. Because the performance characteristics of molecular testtures should be performed, but therapy should not be delayed. The 2 broad categories of pathogenesis: (1) contiguous spread (otitis reported sensitivity of culture for diagnosing tuberculous meningimedia, sinusitis, mastoiditis, and dental infection), trauma, neuthis is 25%–70% [24]. A brain abscess in an immunocompereplaced the India ink stain for rapid diagnosis of meningitis caused tent host is usually caused by bacteria (Table 8). A wider array of by Cryptococcus neoformans or Cryptococcus gattii and should be organisms is encountered in immunocompromised individuals. Encephalitis cultures should also be collected if the shunt terminates in a vascuEncephalitis is an infection of the brain parenchyma causlar space (ventriculoatrial shunt).

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The superficial layer includes five to all natural sleep aid 3 ingredients discount 25 mg sominex free shipping eight rows of flattened cells with small uniform nuclei and a cytoplasm filled with glycogen insomnia oxford ms discount sominex 25mg visa. The nucleus becomes pyknotic sleep aid noise purchase sominex 25mg without prescription, and the cells detach from the surface (exfoliation) insomnia yahoo answers purchase 25mg sominex amex. Columnar Epithelium Columnar epithelium has a single layer of columnar cells with mucus at the top and a round nucleus at the base. The glandular epithelium is composed of numerous ridges, clefts, and infoldings and, when covered by squamous metaplasia, leads to the appearance of gland openings. Technically, the endocervix is not a gland, but often the term gland openings is used. Under stimulation of lower vaginal acidity, the reserve cells proliferate, lifting the columnar epithelium. The immature metaplastic cells have large nuclei and a small amount of cytoplasm without glycogen. As the cells mature normally, they produce glycogen, eventually forming the four layers of epithelium. The metaplastic process begins at the tips of the columnar villi, which are exposed first to the acid vaginal environment. As the metaplasia replaces the columnar epithelium, the central capillary of the villus regresses, and the epithelium flattens out, leaving the epithelium with its typical vascular network. As metaplasia proceeds into the cervical clefts, it replaces columnar epithelium and similarly flattens the epithelium. The deeper clefts may not be completely replaced by the metaplastic epithelium, leaving mucus-secreting columnar epithelium trapped under the squamous epithelium. Some of these glands open onto the surface; others are completely encased, with mucus collecting in nabothian cysts. Their significance was not recognized until 20 years later, when Meisels and colleagues reported these changes in mild dysplasia (7) (Fig. However, a cell culture system for growing keratinocytes was described that allows for stratification and differentiation of specific keratinase types (14). The E6 and E7 oncoproteins are identifiable in the transfected cell lines, providing strong laboratory evidence of a cause-and-effect relationship (15). The normal maturation process and differentiation from the basal and parabasal layers to the intermediate and superficial layers are maintained. In the upper layers, koilocytes are characterized by perinuclear halos, well-defined cell borders, and nuclear hyperchromasia, irregularity, and enlargement. Most women who are exposed have no clinical evidence of disease, and the infection is eventually suppressed or eliminated (17). Factors that may have a role in persistence and progression include smoking, contraceptive use, infection with other sexually transmitted diseases, or nutrition (17,22). This suggests that past exposure and clearance of the virus does not reduce the efficacy of the vaccine. The 3-year follow-up studies of both vaccine products exhibit a reduction in referrals to colposcopy by 26% and 20%, respectively (29,35). This is accompanied by a reduction in excisional procedures of 69% and 42% for the bivalent and quadrivalent products, respectively (29,35). In the vaccine trials in men and boys the protection was 89% at 29 months, leading to approval of this quadrivalent vaccine in males (37). The vaccines are approved for women up to 26 years of age and to be protective they should be effective beyond 10 years. In order to induce a significant antibody response to the antigen, it is combined with an adjuvant. By contrast, the bivalent adjuvant is an aluminum hydroxide combined with a monophosphoryl lipid A. This adjuvant produced higher antibody titers than aluminum-induced titers at the 4-year follow-up visit (39). Because the first vaccinations were given less than 10 years ago, the studies to determine the advisability of a booster are ongoing. The American Committee on Immunization Practices developed recommendations for the utilization of both the quadrivalent and bivalent vaccines in young girls and women. In 2007 the American Cancer Society issued a set of clinical guidelines that remain relevant to the use of these agents (40). For young women between the ages of 19 to 26, there are insufficient data to determine the value of universal vaccination. Screening practices for cervical intraepithelial neoplasia and cancer should remain unchanged in both vaccinated and unvaccinated women. A standardized method of reporting cytology findings facilitated peer review and quality assurance. Pap Test Accuracy Screening for cervical cancer precursors using exfoliative cervico-vaginal cytology, the Pap test was successful in reducing the incidence of cervical cancer by 79% and the mortality by 70% since 1950 (50). However, 20% of women in the United States do not undergo regular screening and have not had a Pap test in the previous 3 years. The annual incidence rate dropped from 8 to 5 cases per 100,000 women, so approximately 8,200 women per year are diagnosed with cervical cancer (50–52). Some cases of cervical cancer continue to occur in patients who have regular Pap tests. A literature review of cervical cytology testing techniques was conducted by the Agency for Healthcare Research and Quality (53). The conclusion was that the sensitivity of conventional cytologic testing in detecting cervical cancer precursor lesions was 51%, with an estimated false-negative rate of 49%. Nearly 30% of new cancer cases each year occur among women who underwent Pap testing. Errors of sampling, fixation, interpretation, or follow-up may be responsible for the missed cases (57). Prior overestimates of Pap test sensitivity of approximately 80% led to erroneous recommendations of screening frequency (58). The conventional Pap test technique needs to be improved in order to reduce falsenegative errors. Sampling errors occur because a lesion is too small to exfoliate cells or the device did not pick up the cells and transfer them to the fixation media. Historically, preparation errors occurred because of poor fixation on the glass slide, leading to air drying and its consequences for interpretation. The slide preparations could be too thick and obscured by vaginal discharge, blood, or mucus. These problems were obviated with the widespread utilization of liquid-based media. Interpretive errors may still occur when the slide contains diagnostic cells that the screening technician or automated detection device fails to identify. The ubiquitous use of liquid-based medium to collect the cytologic sample and preserve the collected cervical cells significantly decreased specimen sampling and preparation errors. With this technique, liquid samples are processed to provide a uniform, thin layer of cervical cells without debris on a glass slide. The Agency for Healthcare Research and Quality assessment of liquid-based cytology improved the sensitivity of the Pap test to the stated goal of 80%. The cell sample is collected with an endocervical brush used in combination with a plastic spatula or with a plastic broom. With this technique, 80% to 90% of the cells are transferred to the liquid media, as compared with the 10% to 20% transferred to the glass slide with conventional cytologic testing. The cells are retrieved from the vial by passing the liquid through a filter, which traps the larger epithelial cells, separating them from the small blood and inflammatory cells. This process yields a thin layer of diagnostic cells properly preserved and more easily interpreted by the cytologist. This technique reduces by 70% to 90% the rate of unsatisfactory samples encountered with conventional cytologic testing (59). Liquid-based cytology is commonly performed by most of the laboratories in the United States.

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For this prescutting girls and women and contribute to insomnia cookies menu buy generic sominex 25mg online the persure to sleep aid 44386 cheap sominex 25mg line disappear insomnia elderly purchase 25 mg sominex fast delivery, the number of people who have petuation of the practice sleep aid for 7 year old generic 25mg sominex with amex. Information regarding the expressed their intention to abandon the practice validity of these justifications helps to change attimust reach a “tipping point”. Once the new convention of valuing a girl’s physical integrity is established, it becomes, like the old conChanging the social convention: vention, self-enforcing. This social pressure tends to perpetuate the Concrete field experience, together with insights practice. It can also be the key to promote rapid colfrom academic theory and lessons learned from the lective abandonment. The practice of footbinding in experience of footbinding in China suggest that six China, for example, which lasted some 1000 years, key elements can contribute to transforming the was abandoned in little more than a generation. A non-coercive and non-judgmental approach group has a convention whereby audiences (at the whose primary focus is the fulfilment of human cinema, at plays, at recitals) stand up rather than sit rights and the empowerment of girls and women. After the shock of surprise when they increase their awareness and underwears off, some people begin to think that sitting standing of human rights and make progress might be better. If only one person sits, that person toward the realisation of those they consider to can’t see anything on the stage. However, if a critical be of immediate concern, such as health and edumass of people in the audience can be organized to cation. An awareness on the part of a community of the mass is needed to bring about change. The critical mass need not be a majority, but simexperiences and those of their daughters. When she leaves the house, she covers herself in a black abaya (garment) and face veil to be properly modest. As a girl, she underwent infibulation, known in Sudan as “pharaonic” cutting, according to Beni Amer tradition. Along with other women, she registered her daughter with the group of uncircumcised girls. Although she doesn’t want her daughter to suffer from the health complications she heard about, she knows that men favour the practice for religious reasons. It is particularly important given up by the community acting together rather to engage those communities that exercise a than by individuals acting on their own. When the decision to abandon ful transformation of the social convention ultibecomes sufficiently diffused, the social dynammately rests with the ability of members of the ics that originally perpetuated the practice can group to organize and take collective action. When the process of abanmost members of a community favor abandondonment reaches this point, the social convention ment. A successful shift requires that they maniof not cutting becomes self-enforcing and abanfest – as a community – the will to abandon. An environment that enables and supports declaration in a large public gathering or an change. Notes 1 Gruenbaum, Ellen (2001), the Female Circumcision Contro9 Gachiri, Ephigenia W. With refversy: An anthropological perspective, University of Pennerence to the Agikuyo of Kenya, Paulines Publication, Nairobi. Stanley, Papa Ousmane Camara, and Baba zanian Media Women’s Association, 21 June 2004. Soumaoro (1999), Female genital cutting and coming of age 11 Dorkenoo, Efua and Scilla Elworthy (1992), Female genital in Guinea, Macro International Inc. Others believe that a woman who has not been cut may become physically deformed or mad, or may Tools for the Prevention of Female Genital Mutilation, procause the death of her husband. The practice is also a violation of the rights of the child to development, protection and participation. It is recognised in Article 3, [] while in the care of parent(s), legal guardian(s) or which calls for the best interests of the child to be any other person who has the care of the child. This principle is of decisive relethe right of an individual to participate in cultural life, vance within the family context. There was also a reluctance to “impose” universal values on what was widely perceived to be a cultural tradition and one that contributed to the collective identity of the communities who practiced it. Moreover, it made a recommendation for the establishment of the Inter-African Committee onTraditional Practices Affecting the Health of Women and Children. The Committee has since played a major role at international level in ensuring that the practice is raised at international conferences and addressed by legal instruments relating to girls and women. The 1979 Convention on the Elimination of All Forms of Discrimination Against Women was a significant milestone in promoting this perspective. In reality, it is strongly subject to tradition mary responsibility for the upbringing and developand culture, community expectations and peer presment of the child. In fulfilling a social and cultural expectation that girls should be cut, parents are the rights to life and to the highest attainable promoting the status and acceptance of their daughstandard of health ters in the community. In some cases, these assigned views of the child being given due weight in accorcauses may be medical in nature, but in others, they dance with the age and maturity of the child. In cases where a girl is in apparent agreement, complications are treated with traditional medicines or it is hard to argue that her consent is truly informed and cures and are not referred to health centres. Moreover, dure to re-open the orifice after it has been stitched there have been few comparisons with uncut women or narrowed and reinfibulation to re-stitch the to establish the relative frequency of these complicavagina may be performed at each birth. Initial analysis of environment, and the physical condition of the girl or the data from some 28,000 women in Burkina Faso, woman. This may, however, ularly when the procedure is carried out in unhygienbe due to factors that prevail over the additional risk ic conditions or using unsterilised instruments. In reality, the medical profession has widely condemned the medicalization of the practice. More fundamentally, “symbolic” interventions do not address the gender-based inequality that drives the demand for this service and may actually inhibit progress toward abandonment of the practice. Here too, scientific research is limited, only has a serious impact on a girl’s personal develbut the anecdotal evidence from girls and women opment, but also on her community, since girls’ eduwho have undergone the practice is testament to the cation and informed participation in social life is a impact it has had on their lives. Girls are generally key to reducing discrimination and promoting develconscious when the operation is performed, and for opment and social progress. In cases where there has been some preparation for the operation, girls are often expected to suppress such feelState obligations ings and collaborate in the proceedings. These measures are relevant and needed at the ness, recurring nightmares, loss of appetite, weight national and subnational levels, and call for the loss or excessive weight gain, as well as panic involvement and mobilization of a wide range of attacks, difficulties in concentrating and learning, and 28 partners, including community leaders and grassother symptoms of post-traumatic stress. Moreover, women who have been sures include promoting awareness-raising and eduinfibulated may be deinfibulated upon marriage, a cation campaigns, developing mechanisms to process that is a source of both pain and, potentially, protect children from these practices, introducing further psychological trauma. In difficulty, individual women or girls may present it in 1995, the Committee held a general discussion about terms of a physical complaint. This discussion emphaamong immigrant communities in Europe, America, sised the importance of the promotion and protecAustralia and New Zealand. The Committee notes with appreciation: [] (e)The prohibition of female genital mutilation under the new Penal Code and the establishment of the National Committee to Combat Female Circumcision []. The Committee urges the State party to continue its efforts to end the practice of female genital mutilation [], inter alia, through enforcement of legislation and implementation of programmes sensitizing the population to their harmful effects. Taking note of the Government’s 1996 decision to prohibit female genital mutilation and the 1997 ministerial decree banning this practice in Ministry of Health service outlets, as well as various efforts to educate the public about the harm caused by this practice, including campaigns in the media and in the curricula, the Committee is concerned that the practice is still widespread. The Committee [] recommends that the State party address the issue of female genital mutilation as a matter of priority. In addition, the State party is urged to design and implement effective education campaigns to combat traditional and family pressures in favour of this practice, particularly among those who are illiterate. The Committee welcomes the efforts made and understands the difficulties faced by the State party in protecting girls within its jurisdiction from female genital mutilation carried out outside its territory. Nevertheless, the Committee urges the State party to undertake strong and effectively targeted information campaigns to combat this phenomenon, and to consider adopting legislation with extraterritorial reach which could improve the protection of children within its jurisdiction from such harmful traditional practices. The Committee is very concerned at the widespread practice of female genital mutilation. The their economic independence, mobilize public opinRecommendation also proposes that States Parties ion, address traditional practices in education curric“include in their national health policies appropriate ula, promote men’s understanding of their roles and strategies aimed at eradicating female circumcision responsibilities and work with communities to prein public health care. It is their duty to adopt States parties to ensure that laws are enacted and a wide range of measures, including an effective enforced to prohibit female genital mutilation.

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For peripheral vascular disease insomnia los angeles generic sominex 25 mg mastercard, must have been confirmed by a vascular surgery evaluation sleep aid all natural generic 25mg sominex visa. The member should contact their primary care physician when they are experiencing pain sleep aid pills cvs purchase 25 mg sominex with amex, ulcers or infection in the feet to insomnia janet jackson no sleep 25mg sominex obtain a referral for these services: Clinical Indication Supporting Information Exclusions the foot care as a Provider office-visit note that indicates the clinical Treatment of flat foot necessary and integral condition being treated. Background Asymptomatic foot care or routine foot care is usually not covered for members in the absence of localized illness, injury or symptoms involving the foot. Kaiser Permanente developed criteria consistent with the Medicare those published by Medicare. Back to Top Date Sent: 8/25/20 469 these criteria do not imply or guarantee approval. Back to Top Date Sent: 8/25/20 470 these criteria do not imply or guarantee approval. The use of Galactin-3 for all other indications does not meet medical necessity because its clinical utility has not been established. In recent years efforts were made to find biomarkers that might help in the risk stratification, and prognostication of acute and chronic heart failure. For a biomarker to be useful to a clinician, it should be available, accurate, and reliable. Gal-3 is also associated with increased age, diabetes, © 2015 Kaiser Foundation Health Plan of Washington. More recently, several automated assays with faster delivery of the results, have been developed and are commercially available. In these studies, blood samples were obtained once at baseline and the plasma was stored for years at temperatures below 70o-80oC. Retrospective analyses may only suggest correlation and not causality; blood samples were obtained only once in the majority of studies, with no serial measurements of Gal-3 and thus cannot determine whether it varies by time and the effects of this variation if any, the plasma samples were frozen, and it is unknown if Gal-3 would degrade over the years. There were variations between the studies in their inclusion criteria, patient characteristics, cause, type, severity, duration, and therapies used for managing the heart failure. These results, however, have to be interpreted with caution due to several limitations. The meta-analysis pooled the results of studies including patients with acute or chronic, © 2015 Kaiser Foundation Health Plan of Washington. Back to Top Date Sent: 8/25/20 472 these criteria do not imply or guarantee approval. Two of the 11 studies included in the analysis were performed by the same principal authors among the same group of patients. The population sizes varied between the included studies from 240 to 1,440 patients, and the follow-up duration ranged between 1 and 8. Back to Top Date Sent: 8/25/20 473 these criteria do not imply or guarantee approval. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. These were obtained from nonfasting blood samples obtained at baseline and stored at 80oC. These 3 endpoints were analyzed in the Galectin-3 substudy by Anand and colleagues (2013). The overall results of this secondary analysis indicate that the use of valsartan was not associated with a beneficial effect on any outcome in this subgroup of patients with available baseline Gal-3 measurements. The authors then arbitrarily categorized patients into two groups based on the median level of Gal-3 (16. The results of these post hoc analyses should be interpreted with caution due to several limitations. The studies did not directly examine the impact of measuring Gal-3 levels on patient management, and/or treatment outcomes. They were secondary analyses that included less than one third of the population in each of the two trials, there were some significant baseline differences between the patients with Gal-3 measurements and the entire participants in each of the studies, Gal3 was measured from specimens obtained at baseline and stored for years, and the results of the trials did not show any significant effect of either drug used (rosuvastatin or valsartan) on the primary outcomes studied. Articles: the literature search revealed over 200 articles on Galectin-3 and heart failure. Criteria | Codes | Revision History enrolled in large cohort studies or randomized controlled trials that investigated different other therapies or interventions. The characteristics of the studies included in the larger meta-analysis as well as selected studies published in the last 5 years and not included in the meta-analyses were reviewed and summarized in Evidence Table 3. Prognostic value of serum galectin-3 in patients with heart failure: a meta-analysis. Elevated plasma galectin-3 is associated with near-term rehospitalization in heart failure: a pooled analysis of 3 clinical trials. Back to Top Date Sent: 8/25/20 475 these criteria do not imply or guarantee approval. Age 18 years or older (Note: age requirement will not be applied to mastectomy in Female-toMale patients if the surgeon, the primary care provider, and the qualified mental health professional unanimously document the medical necessity of earlier intervention) B. The health plan may require a second opinion regarding the patient’s stability prior to surgery if in question. Clear rationale for the variation from the 12-month period of living in desired gender; and c. Patient understands the treatment plan, risks and benefits of surgery prior to completing the 12month period; and d. Age 18 years or older (Note: age requirement will not be applied to augmentation in Male-toFemale patients if the surgeon, the primary care provider, and the qualified mental health professional unanimously document the medical necessity of earlier intervention) E. If significant medical or mental health concerns are present, they must be reasonably well controlled. Twelve months of living in a gender role that is congruent with their gender identity (real life experience) and G. Clear rationale for the variation from either the 12-month period of hormone therapy and/or living for 12 months in desired gender; and c. The plan will determine authorization and consent to care based on medical necessity from the documentation outlined in A-G above. Back to Top Date Sent: 8/25/20 477 these criteria do not imply or guarantee approval. Criteria | Codes | Revision History the criteria above apply for only initial male to female augmentation mammaplasty, any additional breast augmentation after an initial mammaplasty is considered a cosmetic procedure, and therefore, a contract exclusion. Two referral letters from qualified mental health professionals*, one in a purely evaluative role. The duration of the mental health professional’s relationship with the client, including the type of evaluation and therapy or counseling to date. A statement that the mental health professional is available for coordination of care and welcomes a phone call to establish this. Ability to recognize and diagnose co-existing mental health concerns and to distinguish these from gender dysphoria; 4. Back to Top Date Sent: 8/25/20 479 these criteria do not imply or guarantee approval. Criteria | Codes | Revision History Gender Dysphoria refers to discomfort or distress that is caused by a discrepancy between a person’s gender identity and that person’s sex assigned at birth. The therapeutic approach to gender dysphoria consists of three elements: hormones, real life experience and, finally, surgery for some patients. The use of hormone therapy and surgery for gender transition/affirmation is based on many years of experience treating transgender people. Research on hormone therapy is providing us with more and more information on the safety and efficacy of hormone therapy, but all of the long-term consequences and effects of hormone therapy may not be fully understood. Hormone therapy and gender-realignment surgery are superficial changes in comparison to the major psychological adjustments necessary in affirming gender identity. One aspect of treatment should concentrate on the psychological adjustment, with hormone therapy and gender-realignment surgery being viewed as confirmatory procedures dependent on adequate psychological adjustment. Many providers and organizations are moving to an informed consent model for hormones, but surgery still needs involvement of psychology and psychiatry. Psychiatric care may need to be continued for many years after gender-realignment surgery.

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