2: Clinical practice guidelines, Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches The GRADE Working Group, GRADE guidelines: 1. For policy makers: Policy-making will require substantial debate and involvement of various stakeholders. The largest observational study that focused exclusively on primary stroke prevention in a low-middleincome country was conducted in Ibadan, Nigeria, and demonstrated the benefit of hydroxyurea for primary stroke prevention.60 Lagunju et al showed that children with conditional (n = 60) and abnormal (n = 44) TCD velocities taking hydroxyurea that started at 10 mg/kg, escalated to the maximum tolerated dose (20-35 mg/kg), and followed for a mean of 3.6 years had a mean drop in TAMMV from 198 cm/s to 169.3 cm/s. The systematic review did not identify any studies that compared screening to no screening. As new FLAIR sequences are acquired via whole-brain 3D imaging with no gaps between slices, the requirement for imaging in 2 planes to confirm a silent infarct may not be necessary. In 2013, the American Heart Association/American Stroke Association (AHA/ASA) for the first time endorsed a definition of stroke that includes silent cerebral infarctions and silent cerebral hemorrhages typically identified by MRI of the brain.23 This change in definition reflects a shift in emphasis toward a radiological demonstration (tissue-based definition) of infarction or hemorrhage because permanent neurological injury may occur despite symptoms resolving in <24 hours. In a low-middleincome setting, without any primary stroke prevention strategy, 11% of the children with HbSS or HbS0 thalassemia will have a stroke before their 18th birthday.1 For ASHs guidelines to have a significant impact on primary stroke prevention in children with HbSS or HbS0 thalassemia, a meaningful strategy must be aligned with public health policy that can be implemented in children with HbSS living in low-middleincome settings. (A) Axial (left) and coronal fluid-attenuated inversion recovery (FLAIR) images illustrate a qualifying silent cerebral infarct in the left parietal lobe (white arrows). Evidence-based practices for screening for cognitive impairments and rehabilitative interventions for cognitive function, specifically executive dysfunction, are well-established and endorsed practices in professional societies, such as the American Academy of Pediatrics, the American Academy of Neurology, and the American Congress of Rehabilitation Medicine. The type of transfusion (simple, modified exchange, or apheresis) is dependent on individual patient factors and local transfusion resources (strong recommendation based on high certainty in the evidence about effects ). These recommendations include: use of transcranial Doppler ultrasound screening and hydroxyurea for primary stroke prevention in children with hemoglobin SS (HbSS) and hemoglobin S0 (HbS0) thalassemia living in low-middleincome settings; surveillance for developmental delay, cognitive impairments, and neurodevelopmental disorders in children; and use of magnetic resonance imaging of the brain without sedation to detect silent cerebral infarcts at least once in early-school-age children and once in adults with HbSS or HbS0 thalassemia. They also provided key perspectives about families with regard to the importance of having autonomy, being well informed about their neurological morbidity, and knowing the full range of treatment options, even when an option is perceived to be inferior to standard care. Flurbiprofen inhibits heme induced NLRP3 inflammasome in Berkeley sickle cell disease mice. RESULTS: Usable responses from 254 of 574 eligible respondents (44%) were received. The Mayo Evidence-Based Practice Research Program supported the guideline development process, including updating or performing systematic reviews. Individuals with SCD should be treated in a manner similar to that used for the thousands of individuals without SCD, but with brain injury due to stroke or trauma. Following these guidelines cannot guarantee successful outcomes. Each point represents distinct cross-sectional studies in children and adults with HbSS or HbS0 thalassemia.4 Reprinted from Kassim et al with permission.4, One of the panels chief objectives was to establish guidelines applicable to the >95% of children born with HbSS and HbS0 thalassemia in low-middleincome countries. The https:// ensures that you are connecting to the They should never be omitted when quoting or translating recommendations from these guidelines. The systematic review did not identify any comparative studies in SCD that compared cognitive rehabilitation to no rehabilitation. Should simple blood transfusion vs exchange transfusion be used for children and adults with SCD and suspected acute symptomatic stroke, including TIA? A vaso-occlusive crisis occurs when the microcirculation is obstructed . The use of these guidelines is also facilitated by the links to the EtD frameworks and interactive summary of findings tables in each section. For children with HbSC, the risk of abnormal TCD measurements and stroke is less than for those with HbSS.46. The decrease in TCD measurements can occur as early as 3 months after starting hydroxyurea therapy with a sustained impact of hydroxyurea therapy on decreasing TCD measurements for at least 36 months. Although most studies show that opioids provide short-term relief, they are associated with side effects including constipation, opioid-induced hyperalgesia, and risk of . Best practices and implementation strategies for primary stroke prevention after using TCD as a screening tool should be determined. The maximal hemoglobin (Hbmax) to deliver oxygen transport in sickle cell patients is 10 to 11 g/dL because SCD alters red cell viscosity and decreases oxygen transport. Blood Adv. Download PDF 3 MB. For adults with SCD presenting with symptoms of acute ischemic stroke who are being evaluated for IV tissue plasminogen activator (tPA; age 18 years, no hemorrhage on computed tomography [CT] scan, within 4.5 hours of onset of symptoms/signs and without contraindications for thrombolysis), the ASH guideline panel suggests management using a shared decision-making approach that follows these principles: For all patients, the administration of tPA should not delay prompt simple or exchange blood transfusion therapy. Epub 2015 Nov 17. INTRODUCTION Acute pain episodes are the most common reason for individuals with sickle cell disease (SCD) to seek medical attention. The primary premise for our PICO #3 recommendation (see Table 1) is based on the observation that 95% of children with HbSS live in low-middleincome settings,7 coupled with the urgency to prevent strokes in children, in the absence of a randomized controlled trial conducted in low-middleincome settings. Conflicts of interest of all participants were managed through disclosure, panel composition, and recusal, according to recommendations of the Institute of Medicine33 and the Guidelines International Network.14 Participants disclosed all financial and nonfinancial interests relevant to the guideline topic. Telerehabilitation for musculoskeletal pain - An overview of systematic reviews. National Library of Medicine For suspected ischemic strokes, timely and appropriate red blood cell transfusion (within 2 hours of presentation to medical care) should be provided. Framing the question and deciding on important outcomes, Prevention of a first stroke by transfusions in children with sickle cell anemia and abnormal results on transcranial Doppler ultrasonography, Feasibility trial for primary stroke prevention in children with sickle cell anemia in Nigeria (SPIN trial), Intra-individual variation in blood flow velocities in cerebral arteries of children with sickle cell disease, Optimizing Primary Stroke Prevention in Sickle Cell Anemia (STOP 2) Trial Investigators, Discontinuing prophylactic transfusions used to prevent stroke in sickle cell disease, A significant proportion of children of African descent with HbS0 thalassaemia are inaccurately diagnosed based on phenotypic analyses alone, Middle cerebral artery velocity changes during transfusion in sickle cell anemia, Hydroxycarbamide versus chronic transfusion for maintenance of transcranial Doppler flow velocities in children with sickle cell anaemiaTCD With Transfusions Changing to Hydroxyurea (TWiTCH): a multicentre, open-label, phase 3, non-inferiority trial, Effect of transfusion therapy on transcranial Doppler ultrasonography velocities in children with sickle cell disease, Transcranial Doppler in hemoglobin SC disease, Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation, Chronic blood transfusion for primary and secondary stroke prevention in Nigerian children with sickle cell disease: a 5-year appraisal, Silent infarcts in children with sickle cell anemia and abnormal cerebral artery velocity, Association of matched sibling donor hematopoietic stem cell transplantation with Transcranial Doppler velocities in children with sickle cell anemia, Hydroxyurea for sickle cell disease in children and for prevention of cerebrovascular events: the Belgian experience, Hydroxyurea therapy lowers TCD velocities in children with sickle cell disease, Hydroxyurea therapy lowers transcranial Doppler flow velocities in children with sickle cell anemia, Use of hydroxyurea in prevention of stroke in children with sickle cell disease, A pilot study of hydroxyurea to prevent chronic organ damage in young children with sickle cell anemia, Prevention of conversion to abnormal transcranial Doppler with hydroxyurea in sickle cell anemia: a phase III international randomized clinical trial, Hydroxyurea lowers transcranial Doppler flow velocities in children with sickle cell anaemia in a Nigerian cohort, Central nervous system complications and management in sickle cell disease, Changes in transcranial Doppler flow velocities in children with sickle cell disease: the impact of hydroxyurea therapy, Annual stroke incidence in Nigerian children with sickle cell disease and elevated TCD velocities treated with hydroxyurea, Hydroxyurea for children with sickle cell anemia in sub-Saharan Africa, Longitudinal changes in ferritin during chronic transfusion: a report from the Stroke Prevention Trial in Sickle Cell Anemia (STOP), Serum ferritin level changes in children with sickle cell disease on chronic blood transfusion are nonlinear and are associated with iron load and liver injury, TCD With Transfusions Changing to Hydroxyurea (TWiTCH) Trial Investigators, Chronic transfusion practices for prevention of primary stroke in children with sickle cell anemia and abnormal TCD velocities, Stroke Prevention Trail in Sickle Cell Anemia, Prospective RBC phenotype matching in a stroke-prevention trial in sickle cell anemia: a multicenter transfusion trial, Sickle-cell anaemia: report by the Secretariat, Variable degrees of suppression of hemoglobin S synthesis in subjects with hemoglobin SS disease on a long-term transfusion regimen, Increased blood requirements during long-term transfusion therapy for sickle cell disease, Transcranial Doppler screening among children and adolescents with sickle cell anemia, Clinically confirmed stroke with negative diffusion-weighted imaging magnetic resonance imaging: longitudinal study of clinical outcomes, stroke recurrence, and systematic review, Exchange blood transfusion compared with simple transfusion for first overt stroke is associated with a lower risk of subsequent stroke: a retrospective cohort study of 137 children with sickle cell anemia, Red cell exchange transfusions lower cerebral blood flow and oxygen extraction fraction in pediatric sickle cell anemia, Differential cerebral hemometabolic responses to blood transfusions in adults and children with sickle cell anemia, Hemodynamic etiology of elevated flow velocity and stroke in sickle-cell disease, Determinants of resting cerebral blood flow in sickle cell disease, Risk of recurrent stroke in children with sickle cell disease receiving blood transfusion therapy for at least five years after initial stroke, Brain magnetic resonance imaging abnormalities in adult patients with sickle cell disease: correlation with transcranial Doppler findings, Silent infarcts in sickle cell disease occur in the border zone region and are associated with low cerebral blood flow, Red cell exchange: special focus on sickle cell disease, Efficacy and safety of manual partial red cell exchange in the management of severe complications of sickle cell disease in a developing country, Viscosity of mixtures of sickle and normal red cells at varying hematocrit levels. and transmitted securely. tPA administration in a young adult with SCD presenting with an ischemic stroke may delay the administration of regular blood transfusion therapy, a therapy with a clear benefit in this population. To adopt a health care system strategy for tracking TCD assessments and treatment of children with SCD and abnormal TCD measurements because these children are at extremely high risk for ischemic strokes. Search for other works by this author on: Cerebrovascular accidents in sickle cell disease: rates and risk factors, Transcranial Doppler ultrasonography and prophylactic transfusion program is effective in preventing overt stroke in children with sickle cell disease, Chronic and acute anemia and extracranial internal carotid stenosis are risk factors for silent cerebral infarcts in sickle cell anemia, Silent cerebral infarcts and cerebral aneurysms are prevalent in adults with sickle cell anemia, Accuracy of neurologic examination and history in detecting evidence of MRI-diagnosed cerebral infarctions in children with sickle cell hemoglobinopathy, Cognitive function in sickle cell disease across domains, cerebral infarct status, and the lifespan: a meta-analysis, Global epidemiology of sickle haemoglobin in neonates: a contemporary geostatistical model-based map and population estimates, Newborn screening for sickle cell diseases in the United States: a review of data spanning 2 decades. ASH staff and the ASH Guideline Oversight Subcommittee reviewed the disclosures and composed the guideline panel to include a diversity of expertise and perspectives and avoid a majority of the panel having the same or similar conflicts. Alternative treatment strategies, other than regular blood transfusion, for secondary prevention of infarct recurrence in children and adults with silent cerebral infarcts should be developed. For children with SCD who have abnormal surveillance results suggesting increased risk for developmental delay or cognitive impairments, the ASH guideline panel recommends screening or referral for formal screening by a psychologist or a pediatrician able to perform screening with the available validated tools (strong recommendation based on low certainty in the evidence about effects ). The evidence summary and EtD framework can be found online at: https://guidelines.gradepro.org/profile/a34d09131753ee2f22fcaec5b2510f11, https://guidelines.gradepro.org/profile/b9ab114a172cfa3dab8c60ae5d7ba0b0, and https://guidelines.gradepro.org/profile/fe67f197d72505e0299c9557312b83b9. M.R.D. Local or national panels may also use this document as a basis for implementation of strategies to prevent neurological morbidity in children and adults with SCD in their health care system. The utility of TCD screening in children with compound heterozygous SCD is not well defined. The survey queried respondents about their awareness of the NCAA policy and whether they supported universal or targeted screening based on gender, race/ethnicity, level of play, and type of sport. Such resources are likely more available in medical centers with comprehensive care for individuals with SCD than in primary care settings. The panelists rated the importance of outcomes on a scale of 1 to 9, where ratings of 7 to 9 reflect outcomes of critical importance to the decision at hand. was chair of the panel, with CNS content knowledge expertise; M.H.M. The evidence summary and EtD framework can be found online at: https://guidelines.gradepro.org/profile/5bf40c8e961a95877aefa0af3d23dd09. Sickle cell disease (SCD) is a group of complex genetic disorders with multisystem manifestations. The primary purpose for this visit is for the health care provider to reinforce adherence to the therapy, adjust the dose of hydroxyurea due to the increasing weight of the growing child, and evaluate for toxicity, particularly myelosuppression. The panels work was done using web-based tools (www.gradepro.org), as well as face-to-face and online meetings. If 2 or more Hib doses were given before age 12 months, give 1 dose of Hib at least 8 weeks after previous dose. Other purposes are to inform policy, education, and advocacy and to state future research needs. Implementation of the guidelines will be facilitated by the related interactive forthcoming decision aids. What are others saying and what is new in these ASH guidelines? Front Pharmacol. Risk stratification to identify the group of children and adults with strokes likely to have infarct recurrence should be carried out. Applying the results of the Optimizing Primary Stroke Prevention in Sickle Cell Anemia Trial (STOP) has contributed to one of the greatest advances in management of SCD. The full-text version of this article contains a data supplement. Typically, blood transfusion occurs monthly and often requires 2 visits (the first for crossmatching of the red blood cell units and the second for the actual blood transfusion). Available cognitive-screening methods improve detection yet lack sufficient sensitivity to be used as a substitute for clinical judgment.120 For cases in which the patients history, risk factors, and functional complaints indicate a high risk for cognitive impairment, screening may be skipped in favor of directly referring for a comprehensive assessment. The panels absence of any recommendation for HSCT for primary stroke prevention or secondary prevention of infarct recurrence does not reflect an absence of data or priority for the panel, but rather a decision to defer this subject matter to the ASH HSCT Guideline Panel. The individuals most likely to benefit from cognitive rehabilitation therapy should be identified. Should screening with MRI for SCIs vs no screening be used for children and adults with HbSS or HbS, Postoperative complications including postoperative subdural hygroma; seizure; cerebral edema; subarachnoid and interventricular hemorrhage, Intelligence quotient/cognitive impairment, intelligence developmental delay, school performance, Cognitive impairment and school and work performance, Developmental delay, school and work performance, and cognitive impairment, Most individuals in this situation would want the recommended course of action, and only a small proportion would not, The majority of individuals in this situation would want the suggested course of action, but many would not; decision aids may be useful in helping patients to make decisions consistent with their individual risks, values, and preferences, Most individuals should follow the recommended course of action; formal decision aids are not likely to be needed to help individual patients make decisions consistent with their values and preferences, Different choices will be appropriate for individual patients; clinicians must help each patient arrive at a management decision consistent with the patient's values and preferences; decision aids may be useful in helping individuals make decisions consistent with their individual risks, values, and preferences, The recommendation can be adopted as policy in most situations; adherence to this recommendation according to the guideline could be used as a quality criterion or performance indicator, Policymaking will require substantial debate and involvement of various stakeholders; performance measures should assess whether decision-making is appropriate, The recommendation is supported by credible research or other convincing judgments that make additional research unlikely to alter the recommendation; on occasion, a strong recommendation is based on low or very low certainty in the evidence; in such instances, further research may provide important information that alters the recommendations, The recommendation is likely to be strengthened (for future updates or adaptation) by additional research; an evaluation of the conditions and criteria (and the related judgments, research evidence, and additional considerations) that determined the conditional (rather than strong) recommendation will help identify possible research gaps. 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