The stability of the Autism Diagnostic Observation Schedule-2 in children aged 14-36 months with elevated likelihood for autism.

Levocetirizine is a second-generation antihistamine that is the first-line drug recommended by the guidelines for the treatment of chronic urticaria in children. However, the current study focused mainly on adults, and a comprehensive evaluation of children has not been reported. Therefore, comprehensive clinical evaluation of levocetirizine in the treatment of chronic urticaria in children is crucial for providing rational clinical drug use and improving the basis of relevant national policies. To conduct a comprehensive clinical evaluation of levocetirizine in the treatment of chronic urticaria in children and provide a reference for rational drug use and related policy decisions in clinical practice. A comprehensive clinical evaluation index system for the use of antiallergic drugs in children was established via a literature review, expert interviews, and the Delphi method. Evidence was collected to evaluate the safety, efficiency, economy, suitability, accessibility and innovation of levocetirizine and loratadine for the treatment of chronic urticaria in children. The comprehensive clinical evaluation index system included six primary indicators, 12 secondary indicators, and 25 tertiary indicators. The total clinical comprehensive evaluation score of levocetirizine was 92.83, whereas that of loratadine was 72.49. The former is superior to the latter in terms of safety, effectiveness, suitability, innovation, and accessibility, whereas the latter is more cost-effective than the former. The comprehensive clinical value of levocetirizine is greater than that of loratadine in the treatment of chronic urticaria in children, which can provide evidence for the rational use of antiallergic drugs and drug catalog selection in medical institutions.

Introduction Periodontitis is a chronic multifactorial inflammatory disease with significant systemic implications, making early detection essential to prevent tissue destruction and tooth loss. The Periodontal Screening and Recording (PSR) index is widely used as a fast and accessible screening tool, although its diagnostic accuracy remains a subject of debate. Objective To evaluate the diagnostic performance of the Periodontal Screening and Recording (PSR) index in comparison with advanced clinical and radiographic methods, as foundational evidence for the development of a clinical guideline for its implementation. Material and method A scoping review was carried out in accordance with the PRISMA-ScR guidelines. Scientific articles published between 2017 and 2024, in English or Spanish, were included from databases such as Scopus, PubMed, SciELO, and Cochrane. The selected studies were analyzed qualitatively, and their data were systematized into comparative tables to assess the effectiveness and limitations of PSR as a diagnostic tool. Result The evidence indicates that the PSR index is a practical, low-cost, and efficient resource for the initial screening of periodontitis, especially useful in primary care and community settings. However, its ability to determine the severity of the disease or identify the need for surgical intervention is limited in advanced cases. As such, its use should be complemented by comprehensive clinical evaluation and radiographic studies. These findings strengthen the role of PSR as a reliable and time-efficient method for the early detection of periodontal disease. Its simplicity and accessibility make it especially valuable in public health programs and teaching clinics, where rapid screening is essential. The evidence gathered through this review supports the development of a clinical guideline aimed at standardizing its use and ensuring its integration into evidence-based diagnostic protocols. Conclusion The PSR index is an effective and accessible tool for early periodontal screening, particularly in general and public health settings. However, it should be complemented with comprehensive clinical and radiographic evaluation to ensure accurate diagnosis and optimal treatment planning.

BackgroundAnaplastic lymphoma kinase-tyrosine kinase inhibitors (ALK-TKIs) are mainly used in the treatment of ALK-positive advanced non-small cell lung cancer (NSCLC), but a comprehensive clinical evaluation of ALK-TKIs is lacking. Hence, a comparison of ALK-TKIs for first-line treatment of ALK-positive advanced NSCLC is essential to provide rational drug use and a basis for improving national policies and systems.MethodsAccording to the Guideline for the Administration of Clinical Comprehensive Evaluation of Drugs (2021) and the Technical Guideline for the Clinical Comprehensive Evaluation of Antitumor Drugs (2022), a comprehensive clinical evaluation index system of first-line treatment drugs for ALK-positive advanced NSCLC was established by literature review and expert interviews. We conducted a systematic literature review, meta-analysis, and other relevant data analyses, combined with an indicator system, to establish a quantitative and qualitative integration analysis for each indicator and each dimension of crizotinib, ceritinib, alectinib, ensartinib, brigatinib, and lorlatinib.ResultsThe comprehensive clinical evaluation results of all dimensions were as follows: in terms of safety, alectinib had a lower incidence of grade 3 and above adverse reactions; for effectiveness, alectinib, brigatinib, ensartinib, and lorlatinib showed better clinical efficacy, and alectinib and brigatinib have been recommended by several clinical guidelines; in terms of economy, second-generation ALK-TKIs have more cost-utility advantages, and both alectinib and ceritinib have been recommended by the UK and Canadian Health Technology Assessment (HTA) agencies; for suitability, accessibility, and innovation, alectinib has a higher degree of physician recommendations and patient compliance. Except for brigatinib and lorlatinib, all other ALK-TKIs have been admitted to the medical insurance directory; the accessibility of crizotinib, ceritinib, and alectinib is good, meeting the needs of patients. Second- and third-generation ALK-TKIs have higher blood-brain barrier permeability, stronger inhibition ability, and innovation than first-generation ALK-TKIs.ConclusionsCompared with other ALK-TKIs, alectinib performs better across six dimensions and has a higher comprehensive clinical value. The results provide better drug choice and rational use for patients with ALK-positive advanced NSCLC.

The clinical comprehensive evaluation of drugs is an important basis for the return of clinical value, decision-making of medical and health authorities, and allocation of medical resources. In July 2021, the National Health Commission issued the Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), which required the evaluation to be implemented from the six dimensions(safety, effectiveness, economy, innovation, suitability, and accessibility), and made detailed arrangements for the clinical comprehensive evaluation of drugs. As Chinese patent medicine differs from chemical medicines in terms of effective components and action modes, the clinical comprehensive evaluation of Chinese patent medicine should highlight the characteristics and advantages of traditional Chinese medicine(TCM) on the basis of general requirements of comprehensive clinical evaluation of drugs. At present, in the clinical comprehensive evaluation of Chinese patent medicine, unified report standards have not yet been generated, resulting in the uneven quality of existing reports. To standardize the clinical comprehensive evaluation report of Chinese patent medicine and improve its quality, the editorial team, based on the relevant policy documents of clinical comprehensive evaluation of drugs, formulated the clinical comprehensive evaluation report standards for Chinese patent medicine in combination with the previous practice and expert opinions. The report standards, containing seven sections with 15 items determined, focus on data source, evaluation content, evidence synthesis, quality control, and evaluation results supported with detailed interpretations to help researchers better understand and apply the report standards for clinical comprehensive evaluation of Chinese patent medicine, improve the report quality, and provide references for the decision-making by the national medical management authorities.

This study systematically sorted out the existing studies about Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), and conducted comprehensive clinical evaluation through "6+1" dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) to embody the advantages and characteristics and clarify the precise clinical position of Tianshu Capsules. The value of each dimension was calculated via health technology assessment, the multi-criteria decision analysis(MCDA) mo-del and CSC v2.0 software. The results were graded into four levels of A, B, C, or D from high to low. According to the available studies, Tianshu Capsules had low and controllable risks, with the safety rated as A. The drug has obvious clinical significance in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), with the effectiveness rated as A. It has clear economic results, with the economy rated as B. The clinical innovation, service system innovation, and industrial innovation are all good, and thus the innovation of Tianshu Capsules is grade A. The drug can meet clinical medication demand of medical care and patients, and thus its suitability is grade A. In view of the reasonable drug price, affordability, and availability, the accessibility is grade A. The prescription originated from the Daxiong Pills recorded in the classic Comprehensive Recording of Sage-like Benefit. In clinical trials, 4 675 patients have used Tianshu Capsules, which indicates rich experience in human administration, and the characteristics of traditional Chinese medicine is grade B. The statutory drug information complies with national stan-dards, and the non-statutory information is standard and accurate. Based on the comprehensive evaluation results of various dimensions of evidence, the clinical value of Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals and syndrome of ascendant hyperactivity of liver Yang) is class A. According to the Comprehensive Clinical Evaluation Management Guidelines of Drugs(trial version 2021) issued by the National Health Commission of the People's Republic of China, we recommend that Tianshu Capsules treating migraine can be transformed into relevant policy results for clinical medication management according to procedures.

This study evaluated the clinical effectiveness of Ruyi Zhenbao Pills in the treatment of osteoarthritis, aiming to clarify its clinical advantages and promote rational drug use and related policy transformation. Following the relevant standards in Guidelines for the Comprehensive Evaluation of Drugs in Clinical Practice and Technical Specifications for the Clinical Comprehensive Evaluation of Chinese Patent Medicine, comprehensive research and related data on Ruyi Zhenbao Pills in the treatment of osteoarthritis were collected in the dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and traditional Chinese medicine(TCM) cha-racteristics(referred to as the "6+1" dimensions). Through evidence-based medicine, questionnaire surveys, health technology assessment, pharmacoeconomic evaluation, and other methods, a multi-criteria decision analysis(MCDA) model and CSC v2.0 software were used to comprehensively evaluate the clinical value of Ruyi Zhenbao Pills. Spontaneous reporting system data on adverse reactions and literature data indicate that the adverse reactions of Ruyi Zhenbao Pills are mostly general adverse reactions, with no reports of se-rious adverse reactions. The known risks are small, and its safety is rated as class A. It has been shown to effectively relieve joint pain and restore joint function in the treatment of osteoarthritis. However, more high-quality, large-sample randomized controlled trials are needed to further validate its effectiveness, which is rated as class B. There is evidence supporting its economic viability, and its economic is rated as class B. It demonstrates good clinical innovation, innovative enterprise service system, and industrial innovation, and innovation is rated as class A. Medical professionals and patients have a favorable perception of the suitability of Ruyi Zhenbao Pills, and further improvement can be made in terms of convenience of administration and promotion to facilitate rational drug use by healthcare professionals and patients. Suitability is rated as class B. The drug has a favorable price level, availability, and affordability, and accessibility is rated as class A. Ruyi Zhenbao Pills are a classic Tibetan medicinal prescription with excellent TCM theoretical characteristics. However, further research is needed on its use in human studies. TCM characteristics are rated as class B. Based on the evaluation results of the "6+1" dimensions, the comprehensive clinical evaluation is rated as grade B. Ruyi Zhenbao Pills have good clinical value in the treatment of osteoarthritis, and it is recommended to undergo the necessary procedures for conditional transformation into a policy for the management of essential clinical drugs.

Clinical pharmacopsychology is an area of clinical psychology that is concerned with the application of clinimetric methods to the assessment of psychotropic effects of drugs on psychological functioning, and the interaction of such drugs with specific or non-specific treatment ingredients. Clinical pharmacopsychology derives its data from observational and controlled studies on clinical populations and refers to the therapeutic use of medical drugs, not to the effects of substances used for other purposes. Domains and operational settings of clinical pharmacopsychology are illustrated. The domains of clinical pharmacopsychology extend over several areas of application which encompass the psychological effects of psychotropic drugs (with particular emphasis on subclinical changes), the characteristics that predict responsiveness to treatment, the vulnerabilities induced by treatment (i.e., side effects, behavioral toxicity, iatrogenic comorbidity), and the interactions between drug therapy and psychological variables. A service for clinical pharmacopsychology is here proposed as an example of the innovative role of clinical psychology in medical settings. Clinical pharmacopsychology offers a unifying framework for the understanding of clinical phenomena in medical and psychiatric settings. Its aim is to provide a comprehensive assessment of the clinical important changes that are concerned with wanted and expected treatment effects; treatment-induced unwanted side effects; and the patient's own personal experience of a change in terms of well-being and/or quality of life. It is now time to practice clinical pharmacopsychology, creating ad hoc services in Europe. Clinical pharmacopsychology assesses the effects of medications on psychological functioning Since clinical psychologists visit medicated patients, a comprehensive clinical evaluation is crucial Vulnerabilities induced by psychotropic drugs are an important area of application of clinical pharmacopsychology Clinical pharmacopsychology assesses the effects of medications on psychological functioning Since clinical psychologists visit medicated patients, a comprehensive clinical evaluation is crucial Vulnerabilities induced by psychotropic drugs are an important area of application of clinical pharmacopsychology

Purpose:To retrospectively study impact of preoperative posterior segment evaluation on surgical intervention in camp patients recruited for cataract surgery in Gujarat India.Methods:Retrospective analysis of six months data collected from hospital electronic medical record (EMR) system of 9820 admitted patients recruited from screening camp for cataract surgery from 1/10/2019 to 31/3/2020 in Tertiary Eye Hospital in Gujarat, India, has been done. Comprehensive clinical evaluation, of both anterior and posterior segment which included detailed history; best corrected visual acuity (BCVA); intraocular pressure measurement with non-contact tonometer (NCT) and when required with Goldman applanation tonometer; slit lamp examination; and fundus examination with + 90 diopter lens as well as indirect ophthalmoscope as and when indicated. In case there was no view of retina, a B-scan ultrasound was done to rule out any posterior segment pathology. Immediate surgical intervention done was assessed and results analyzed in percentage.Results:Cataract surgery was advised for 8390 patients (85.43%). Surgical intervention for management of glaucoma was done for 68 patients (0.692%). Retina intervention was done for 86 patients. Posterior segment evaluation changed immediate surgical plane of management for 154 (1.57%) patients.Conclusion:Comprehensive clinical evaluation is economical and should be mandatory especially in community services as comorbid conditions like glaucoma, diabetic retinopathy, retinal vein occlusion, and other varied posterior segment diseases contribute significantly to visual disability in elderly age group. It is difficult to follow these patients later if manageable comorbidity is not informed about and if indicated dealt simultaneously for visual rehabilitation of patient.

Editor's choice

To the Editors: The coronavirus disease 2019 (COVID-19) pandemic has had a significant impact on the health of people around the world.1 While thrombotic complications have been widely reported in adult patients with COVID-19, recent studies have shown that children with the disease can also experience the events. These complications associated with COVID-19 include deep vein thrombosis, pulmonary embolism, ischemic stroke and arterial thrombosis.1 Thrombotic complications can be fatal and require immediate diagnosis and treatment, including the use of COVID-19–associated thrombotic response syndrome in children.2 This case report presents a pediatric patient with COVID-19 who developed thrombotic manifestations. A 3-year-old girl living in the northeast region of Brazil and presenting a history of nonprogressive chronic encephalopathy due to perinatal anoxia was admitted to the hospital with fever, dry cough and dyspnea. The child was lethargic and had clinical signs of acute respiratory failure requiring mechanical ventilation and care in the pediatric intensive care unit. A COVID-19 Reverse-Transcriptase Polymerase Chain Reaction was positive. After spending a few days in the hospital and exhibiting persistent signs of shock, such as high ventilation parameters and constant drops in oxygen saturation even with invasive ventilation and high levels of oxygen, the patient developed thrombotic lesions on the right hand. The patient underwent venous Doppler ultrasound in the region of the right hand and wrist, which showed the presence of intraluminal content, as well as a significant reduction in blood flow. Dilation of the veins is also observed, indicating the presence of blood accumulation. Such findings being consistent with thrombosis in the radial, ulnar and median veins, with partial occlusion of blood flow. Laboratory tests showed increased D-dimer (2996 ng/mL) and ferritin levels (1136 ng/mL), decreased platelet count (110,000/μL), and persistent lymphopenia. Chest radiograph revealed bilateral infiltrates. In addition, a contrast-enhanced computed tomography of the chest showed the presence of areas of opacity in a ground-glass pattern bilaterally and disused, associated with parenchymal consolidations, observed predominantly in the bilateral lung bases, in addition to showing the presence of microthrombi in pulmonary veins and a small effusion bilateral pleural and consolidation. Such tomographic findings suggested a pulmonary thromboembolic phenomenon. Further evaluation revealed that the thrombotic lesion on the patient’s right hand was caused by COVID-19–associated thrombotic response syndrome. The patient was immediately started on full anticoagulant therapy, beginning with heparin and later switching to enoxaparin, and continued to receive intensive supportive care. In addition, the patient underwent corticosteroid therapy with methylprednisolone. No other thrombotic events were observed. After 27 days of intensive care, the patient showed clinical improvement and was transferred to a room, while still receiving anticoagulants treatments. The presence of elevated D-dimer and ferritin are observed in many children with acute COVID-19 and multisystem inflammatory syndrome in children (MIS-C), who often respond to treatment with the use of corticosteroids and the use of immunoglobulin. In this case, the presence of venous thrombosis in the right hand, evidenced by the Doppler ultrasound, the presence of microthrombi in the veins and pulmonary branches found in the chest tomography, were decisive for differences and to define that the thrombotic manifestations present in this case had a greater clinical impact and from the point of view from the pathophysiological point of view with activation of prothrombotic factors. The comprehensive evaluation, adding the clinical, laboratory and imaging context, confirms the presence of thrombotic injury in the child’s venous system, because of the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in that child, requiring intervention with the use of anticoagulants in therapy. This case report is peculiar due to the presence of thrombotic events, refractory hypoxemia and increased markers (D-dimer and ferritin), which increased case severity. In addition, the use of anticoagulant therapy, such as heparin and enoxaparin, was fundamental in reversing the proinflammatory state. The manifestations of the thrombotic response associated with COVID-19, remain a syndrome with the set of clinical laboratory and imaging findings, are fundamental for the diagnosis. Criteria proposed by a consensus of Spanish experts who call such manifestations RITAC Syndrome propose the presence of one or more of the following criteria: D-dimer >1000 ng/mL, ferritin >500 ng/mL, rapidly progressive dyspnea, refractory hypoxemia, events thrombosis and shock.2 However, it is important to note that these criteria are very nonspecific and have not been validated, particularly in the pediatric population, and may not be applicable to all clinical situations. Therefore, the diagnosis must be individual and unique based on a comprehensive clinical evaluation, including laboratory and imaging tests. Treatment of manifestations of the COVID-19–associated thrombotic response is important to avoid thrombotic complications. This may include administering anticoagulants such as heparin and enoxaparin.3 While both conditions can occur in pediatric patients with COVID-19, MIS-C and COVID-19–associated thrombotic response syndrome are different conditions with distinct pathophysiological mechanisms and clinical presentations. MIS-C is characterized by a generalized inflammatory response, while COVID-19–associated thrombotic response syndrome is characterized by a prothrombotic state that increases the risk of blood clots.4,5 In terms of clinical presentation, MIS-C is characterized by symptoms such as persistent fever, widespread body inflammation and involvement of multiple organ systems such as the heart, lungs, gastrointestinal tract and central nervous system.4 On the other hand, COVID-19–associated thrombotic response syndrome is described by a prothrombotic state that increases the risk of blood clots, leading to serious complications such as deep vein thrombosis, pulmonary embolism and stroke.5 Another important factor is that the same patient may present both MIS-C and COVID-19–associated thrombotic response syndrome, requiring a combined approach.6 Describing a case report that helps identify possible cases associated with thrombotic phenomena is essential, as it highlights the importance of early diagnosis and therapeutic management. Figure 1 describes the diagnostic findings and suggested management.FIGURE 1.: Schematic description of the definition, proposed criteria and performed therapy. COVID-19 indicates coronavirus disease 2019; CT, computed tomography; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.

Identification of specific causes of myelopathy in a large cohort of patients initially diagnosed with transverse myelitis

Frequency of Abnormal Findings Detected by Comprehensive Clinical Evaluation at 1 Year after Allogeneic Hematopoietic Cell Transplantation

The objective was to provide a basis for the rational clinical application of moxifloxacin through its comprehensive clinical evaluation, and to serve as a reference for the clinical comprehensive evaluation of relevant drugs in the future. We obtained data from 91 community-acquired pneumonia patients admitted to Weifang people's hospital from April 2020 to November 2021, including 46 in the evaluation group and 45 in the control group. Based on the requirements of the "Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs" (for trial implementation), systematic evaluations are conducted in terms of drug safety, effectiveness, economy, innovation, suitability, and accessibility. The incidence of adverse drug reactions was low, drug quality, safety and stable efficacy; treatment efficiency was 91.3% and 93.3%, respectively (P > .05); the average total cost of the evaluation group was 9765.28RMB and 10250.69RMB, respectively; efficient cost-effectiveness ratio was 104.67 and 112.52 and cost-effectiveness ratio was 242.71. The economy of the evaluation group had a low price and was highly available.

Through investigating the current research on the effect of Naoxintong Capsules in the treatment of cerebral infarction with Qi deficiency and blood stasis syndrome and coronary heart disease angina pectoris, this study conducted a clinical comprehensive evaluation in "6+1" dimensions [safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM)], so as to highlight the advantages and clinical value of Naoxintong Capsules. By combining qualitative and quantitative methods, we used the multi-criteria decision analysis(MCDA) model to measure each dimension, and the results thereby were divided into four grades of A, B, C, and D in high-to-low order. Through literature review and evaluation, the adverse effects of Naoxintong Capsules are mainly caused by the gastrointestinal system. Since the safety risk is controllable based on current research, the safety evaluation is grade B. The effectiveness of Naoxintong Capsules combined with conventional western medicine in the treatment of cerebral infarction with Qi deficiency and blood stasis syndrome and coronary heart disease angina pectoris is evaluated as grade A, as compared with conventional therapy alone. The economy of Naoxintong Capsules, compared with Tongxinluo Capsules, is assessed as grade B. According to literature reports, Naoxintong Capsules exhibits outstanding clinical innovation in optimizing the current anti-platelet therapy strategy for patients with coronary heart disease after percutaneous coronary intervention(PCI), and the innovation is class A. Given the capsule formulation is convenient for storage and transportation, and its usage is easy for patients to grasp and accept, the suitability is grade B. The accessibility is grade A considering the price level, availability, and affordability, and the characteristics of TCM are evaluated as grade A from the perspectives of theoretical characteristics and human experience. The results of the comprehensive drug evaluation showed that the clinical value of Naoxintong Capsules is class A for treating cerebral infarction with Qi deficiency and blood stasis syndrome and coronary heart disease angina pectoris. According to the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs(trial 2021 version) issued by the National Health Commission, relevant policy results for basic clinical drug management can be formulated directly by procedure.

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