Global Assessment Scale Research Articles

Construction and validation of a predictive model for the risk of three-month-postoperative malnutrition in patients with gastric cancer: a retrospective case-control study.

This study analyzed both the influencing factors of malnutrition in patients with gastric cancer and established a multi-dimensional risk model to predict postoperative malnutrition three months after surgery. The clinical data of gastric cancer patients hospitalized for the first time and receiving laparoscopic surgery in the general surgery department of our hospital were retrospectively analyzed through the hospital information system and divided into a training set and a validation set in the ratio of 7:3. Nutritional status was assessed using the Patient Generated Subjective Global Assessment scale and follow-up records three months after surgery. Patients were divided into a non-malnutrition group and a malnutrition group, and a risk prediction model was established and displayed in the form of a nomogram. A total of 344 patients were included, with 242 in the training and 102 in the validation set. Tumor node metastasis stage (TNM Stage, P=0.020), cardiac function grading (CFG, P=0.013), prealbumin (PAB, P<0.001), neutrophil-to-lymphocyte ratio (NLR, P=0.027), and enteral nutrition within 48 hours post-operation (EN 48 h post-op, P=0.025) were independent risk factors. We established a prediction model with the above variables and displayed it via a nomogram, then verified its effectiveness through internal and external verification. This revealed a C-index of 0.84 (95% CI: 0.79-0.89), and the area under curve (AUC) areas of 0.840 (training set) and 0.854 (validation set), which was better than the nutritional risk screening 2002 (NRS2002) scale. The calibration curve brier scores were 0.159 and 0.195, and the Hosmer-Lemeshow test chi-square values were 14.070 and 1.989 (P>0.05). The decision curve analysis (DCA) of the training set model indicated the clinical applicability was good and within the threshold probability range of 10%-85%, which was also better than NRS2002. A clinical prediction model including multi-dimensional variables was established based on independent risk factors of malnutrition three months after gastrectomy in patients with gastric cancer. The model yields greater prediction accuracy of the risk of three-month-postoperative malnutrition in patients with gastric cancer, helps screen high-risk patients, formulates targeted nutritional prescriptions early, and improves the overall prognosis of patients.

An evaluation of the effectiveness of a therapeutic program for children with global developmental delay

PurposeGlobal developmental delay (GDD) is highly prevalent among patients at child psychiatry clinics. However, preschool day treatment centers are currently scarce. As such, this study aimed to evaluate a program that was designed for children with GDD in order to improve their global skills and prepare them to join the school system.Design/methodology/approachThis study utilized an observation retrospective design with a comparative group sample and included all children aged between 3 and 6 years who participated in the program for at least one academic year (experimental group). Their GDD diagnoses were based on the DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders). Children with similar diagnoses who were on the waiting list constituted the control group. Pre- and post-scoring of the Children’s Global Assessment Scale (CGAS) were conducted by the children’s teacher and blinded investigator for the experimental group, while the children’s mothers conducted the post-CGAS scoring for the control group.FindingsThe pre- and post-CGAS scores for the experimental group were 49.5 ± 12.8 and 58.3 ± 12.7 and 47.3 ± 17.3 and 66.6 ± 17.3 for the control group, respectively (p = 0.001). The children in the experimental group scored significantly better than the control group with respect to securing places in integrated, regular classes in the education system (p = 0.001).Research limitations/implicationsThis study had certain limitations. First, the number of children in the control group was relatively small. Second, the baseline skill levels of some of the children in the control group may have been lower than those of the children in the experimental group at the beginning of the evaluation; this may explain why they had been put on the waiting list. Third, the information was gathered retrospectively; this is a method that is known to have its own limitations.Practical implicationsThe clinical implications of the study are that the early identification and referral of GDD are key elements in the rehabilitation of these children and that early intervention programs are necessary for cases of moderate and severe GDD. Primary care physicians should follow up with GDD patients to ensure that referrals are being appropriately sought (Choo et al., 2019).Originality/valueThe program was effective in both increasing the general functioning skills of the children in the experimental group and preparing them to attend regular, integrated classes. The program should be expanded and made available to more children with GDD.

357 The effect of upadacitinib on the genital region in moderate-to-severe atopic dermatitis: an analysis from the Measure Up 1 and Measure Up 2 studies

Abstract Atopic dermatitis (AD) is a chronic, inflammatory skin disease that can be debilitating, impacting all body areas, including the genital region. Genital AD results in impairments in daily activity levels, sexual function and sleep, contributing to impaired quality of life in patients with moderate-to-severe AD. Upadacitinib (UPA) is a selective oral Janus kinase (JAK) inhibitor with greater inhibitory potency for JAK1 vs. JAK2, JAK3 and tyrosine kinase 2, indicated for the treatment of moderate to severe AD. The SCORing Atopic Dermatitis (SCORAD) measure assesses the extent and severity to which a body area is affected, as well as itch and sleeplessness due to AD. In this post-hoc analysis of the Measure Up 1 and Measure Up 2 studies, we evaluated the proportion of patients whose genital AD resolved with UPA 15 mg or UPA 30 mg compared with placebo. Measure Up 1 and 2 are phase 3 multicenter, randomized, double-blind studies comparing the safety and efficacy of UPA 15 mg and UPA 30 mg to placebo in adolescent and adult patients with moderate-to-severe AD. Patients were randomized to oral once daily UPA 15 mg, UPA 30 mg or placebo. The current study assessed the proportion of patients with genital involvement at baseline who achieved genital AD resolution at week 2 and week 16 based on data collected from the SCORAD. Non-responder imputation was used. Of the 1679 participants, 239 (14.2%) had genital AD at baseline and were randomized to UPA 15 mg (n = 77), UPA 30 mg (n = 86) or placebo (n = 76). More participants with genital involvement vs. those without were male (61.1% vs. 54.1%), ≥18 years old (92.1% vs. 85.5%), and severe according to the Validated Investigator Global Assessment Scale for Atopic Dermatitis (66.9% vs. 47.2%) at baseline. On average, participants with genital involvement at baseline also reported greater disease duration (25.0 vs. 22.8 years) and higher Dermatology Life Quality Index (DLQI) scores (19.2 vs. 16.3). At week 2, the proportion of patients whose genital AD was resolved was 70.1% of the UPA 15 mg group, and 82.6% of the UPA 30 mg group, both of which were greater than the placebo group (31.6%; P &amp;lt; 0.001). At week 16, the proportion of patients whose genital AD was resolved increased in the UPA 15 mg (80.5%) and UPA 30 mg (83.7%) groups, but not in the placebo group (28.9%) which remained lower than both groups (P &amp;lt; 0.001). More patients with moderate-to-severe AD achieved resolution of their genital AD with UPA 15 mg or 30 mg monotherapy daily compared to placebo, with &amp;gt;70% rapidly achieving genital AD resolution after 2 weeks and &amp;gt;80% after 16 weeks of UPA treatment. In addition to overall improvements in moderate-to-severe AD with UPA, resolution of genital AD may correspond to improvements in sexual functioning, reductions in sleeplessness and greater quality of life. These findings underscore the importance of considering genital involvement when assessing the burden of AD to comprehensively inform integrated shared decision-making treatment discussions between patients and physicians.

Clinical Research Updates.

Clinical Research Updates.

Efficacy and Safety of Autologous Serum Therapy in Chronic Spontaneous Urticaria in the Pediatric Population: A Prospective Pilot Study.

Chronic spontaneous urticaria (CSU) in children is mostly spontaneous in onset (57%). Treatment comprises long-term antihistaminic therapy without need for elaborate investigations. A subset of such patients don't respond to conventional treatment and novel therapies to help reduce pill burden is the need of the hour. To determine the efficacy and safety of autologous serum therapy (AST) in pediatric patients with chronic spontaneous urticaria. All pediatric patients, aged between 6-16 years, attended to our OPD from March 2019 to March 2020 were recruited. Clinico-demographic data and baseline investigations of all patients were performed. Two-weekly AST therapy was given for 8 visits with levocetrizine tablet 5mg on an on-demand basis. Urticaria activity score (UAS) sheet was provided to record and return every 2 weeks. Statistical analysis was done using the IBM SPSS 26 software package. Autologous serum skin test (ASST) was positive in 63% patients. Both the ASST positive and ASST negative group showed significant reduction in UAS7 score at week 14 compared to baseline. The reduction in mean UAS7 score was associated with a decreased pill burden and positive response in the patient and physician global assessment scale. No statistically significant difference between the two groups in terms of mean UAS7 reduction was found. This study has explored the efficacy and safety of autologous serum therapy in the pediatric CSU patients. Both ASST positive and ASST negative group respond to AST therapy.

Assessment of the efficacy and safety of platelet rich plasma gel injection in facial rejuvenation and wrinkles

Background: Changes in the three-dimensional geometry of the underlying structures contribute to the ageing process of the human face, just as the skin's surface textural wrinkling does. Objective: To evaluate the efficacy and safety of platelet rich plasma gel injection in facial rejuvenation and facial wrinkles. Methods: This study was carried out on 10 subjects presented by facial wrinkles. Patients were subjected to platelet rich plasma gel injection after taking an informed consent. They were assessed clinically by global assessment scale before treatment and at the end of follow up period. Results: After administration of plasma gel, all subjects significantly improved clinically immediately. This finding confirmed by significant improvement of global assessment scale. Conclusions: Plasma gel seem to be safe, effective and well tolerated in treatment of facial wrinkles and rejuvenation.

Rare presentation of Ulcerative Lichen Planus (Bars-e-Aswad Quroohi) – A Case Study

Introduction: Lichen planus is a T-cell-mediated autoimmune inflammatory disorder of the skin and mucous membranes. It appears as pruritic, violaceous papules and plaques most found on the wrists, lower back, and ankles. This paper presents the case of 32 years old married female patient, who came to the National Institute of Unani Medicine OPD Bengaluru. Clinical presentation: Her chief complaints were severe pain, itching, and ulcerated lesions on the dorsal and plantar aspects of feet with loss of all the toenails for eight years. The lesions appeared as erythematous papules on dorsal surface of both big toes of feet and spread to the plantar aspect. Initially, lesions were violaceous, scaly and dry. Later, painful fissures developed with oozing of blood. As disease progresses, nails of feet are involved leading to anonychia. Diagnosis: The patient was diagnosed clinically as ulcerative lichen planus resembled to Bars-e-Aswad Qroohi in the Unani system of medicine. Interventions: The patient was treated with Joshanda Munzij Sauda (decoction) and Majoon Ushba (compound formulation) orally and Marham Asfeedaj for local application after foot bath from Safoofe Zaj. Outcome: Assessment of efficacy was done by physician global assessment (PGA) scales in three parameters (pruritus, pain, and fissure) before and after treatment. Conclusion: This Unani formulation effectively improves pruritus, pain, scaling, and fissures in Ulcerative lichen planus and may be considered for complimentary management of ULP.

Comparative Evaluation of Efficacy of Jati Ghrita and 1% Chlorhexidine Gluconate on Aphthous Stomatitis- A Research Protocol for Randomised Control Trial

Introduction: Aphthous ulcer is seen to be one of the most commonly occurring ailments found among patients that dentists may come across on a daily basis. Taking into consideration, the agents that have been used for treatment of Aphthous stomatitis safety, least toxic properties with symptomatic relief and topical application are considered. These days there are few reliable natural remedies which are emerging as a therapy for aphthae. Herbal and polyherbal medicines will alleviate pain, induce healing, prevent infection and lessen inflammation in aphthous ulcers without any adverse effects. Aim: To evaluate and compare the efficacy of Jati Ghrita and 1% chlorhexidine gluconate on aphthous stomatitis patients. Materials and Methods: A randomised control trial will be carried out for an expected time of 3-4 months, in the Department of Oral Medicine and Radiology, Sharad Pawar Dental College and Dattatray Ayurvedic Rasashala, Wardha, Maharashtra, India. The study population consisting of 30 patients (age 18-65 years) with Aphthous stomatitis will be divided randomly into two groups i.e., Jati Ghrita and 1% Chlorhexidine gluconate, each group consisting of 15 patients. Efficacy will be assessed by patient’s response through Visual Analogue Scale (VAS) and oral physician’s observation-5 point Investigator’s Global Assessment (IGA) scale. The intergroup comparison will be done by independent sample t-test. Expected Results: Jati Ghrita is expected to be effective in faster healing of aphthous stomatitis with reduction in pain. Jati is also expected to be more effective than 1% chlorhexidine gluconate. Conclusion: Hence, this study will evaluate and compare the efficacy of Jati Ghrita and 1% chlorhexidine gluconate on aphthous stomatitis

Clinical Evaluation of Conditioned Media of Human Umbilical Cord Blood Mesenchymal Stem Cells for Improvement of Symptoms of Sensitive Skin: Prospective, Single Blinded, Split-face Study.

The exact definition of sensitive skin is not established yet. Since its high prevalence and significant influence on quality of life, it has become an important topic of research. Among various ingredients, conditioned media from umbilical cord blood-derived mesenchymal stem cells (UCB-MSC-CM) can be a promising source for the treatment of sensitive skin. We evaluated the efficacy and safety of UCB-MSC-CM on patients with sensitive skin. We designed a randomized, single blinded, prospective, split-face comparison study and enrolled thirty patients. All patients underwent nonablative fractional laser over the entire face before UCB-MSC-CM or normal saline was applied. Each facial area was randomly assigned to undergo treatment with either UCB-MSC-CM or normal saline. We performed three sessions at two-week intervals, and final results were assessed on six weeks after the last session. As an outcome measure, we evaluated a five-point global assessment scale, transepidermal water loss (TEWL), erythema index (EI) and Sensitive Scale-10. Twenty seven subjects were included in final analysis. The treated side exhibited greater improvement compared to the untreated side based on a five-point global assessment scale. TEWL, EI of the treated side were significantly lower than those of the untreated side throughout study period. Sensitive Scale-10 was significantly improved after treatment. The application of UCB-MSC-CM resulted in improved skin barrier function and reduced inflammatory responsiveness, which could provide beneficial effect on sensitive skin.

Long-Term Follow-Up of Lower Urinary Tract Outcome in Children with Dysfunctional Voiding.

Objective: To investigate the long-term clinical and urodynamic outcomes of a small cohort of children who received short-term urotherapy for confirmed dysfunctional voiding (DV) and lower urinary tract symptoms (LUTS). Materials and Methods: This study included 26 children with confirmed LUTS and DV via video urodynamic study (VUDS) and received standard urological therapy, pelvic floor muscle training, or surgical intervention in childhood. Their current lower urinary tract conditions were assessed by chart review and direct and telephone interviews. Charts of 14 patients who underwent follow-up VUDS were reviewed to investigate their bladder and voiding dysfunction or follow-up on previous treatment results. The satisfaction of lower urinary tract status was assessed using the global response assessment (GRA) scale. Results: At initial enrolment, the mean age was 9.54 ± 3.88 years, and urological treatment was performed during the first 1-5 years thereafter. Most patients were not regularly followed in the urology clinic. Among the 14 children available for follow-up, a GRA score of 3 was reported by 10 (71.4%) after a mean follow-up period of 10.3 ± 6.74 (range, 2-20) years, indicating satisfactory bladder and voiding conditions. Four children with less favorable outcomes (GRA score of &lt;3) had significantly more post-void residual urine volume at baseline, and 75% of these patients had central nervous system diseases. Daytime incontinence and enuresis rates were significantly decreased at follow-up compared with the baseline. Significantly increased bladder capacity and sensation and significantly decreased voiding detrusor pressure were found on follow-up VUDS. Conclusions: Children with DV who received standard urotherapy upon diagnosis exhibited improved LUTS at a 10-year follow-up. Of the 14 children available for follow-up, 10 (71.4%) reported satisfactory bladder and voiding status without further medication or urotherapy, with significantly decreased voiding detrusor pressure.

Treatment Outcomes of Intravesical Botulinum Toxin A Injections on Patients with Interstitial Cystitis/Bladder Pain Syndrome.

Botulinum toxin A (BoNT-A) is effective in reducing bladder hypersensitivity and increasing capacity through the effects of anti-inflammation in the bladder urothelium; however, studies on the treatment outcome of interstitial cystitis/bladder pain syndrome (IC/BPS) are lacking. We investigated the treatment outcome in IC/BPS patients receiving intravesical BoNT-A injections. This retrospective study included IC/BPS patients who had 100U BoNT-A intravesical injections in the past 20 years. The treatment outcomes at 6 months following the BoNT-A treatment were evaluated using the global response assessment (GRA) scale. The treatment outcomes according to the GRA scale include clinical symptoms, urodynamic parameters, cystoscopic characteristics, and urinary biomarkers, and it was these predictive factors for achieving satisfactory outcomes which were investigated. Among the 220 enrolled patients (180 women, 40 men) receiving BoNT-A injections, only 87 (40%) had significantly satisfactory treatment outcomes. The satisfactory group showed significantly larger voided volumes, and lower levels of both the urinary inflammatory protein MCP-1 and the oxidative stress biomarker 8-isoprostane in comparison to the unsatisfactory group. The IC severity and detrusor pressure are predictive factors of BoNT-A treatment outcomes. IC/BPS patients with less bladder inflammation showed satisfactory outcomes with intravesical BoNT-A injections. Patients with severe bladder inflammation might require more intravesical BoNT-A injections to achieve a satisfactory outcome.

GC1f Vitamin D Binding Protein Isoform as a Marker of Severity in Autism Spectrum Disorders.

Autism spectrum disorders (ASD) are characterized by a wide spectrum of clinical, behavioral, and cognitive manifestations. It is, therefore, crucial to investigate possible biomarkers associated with specific ASD phenotypes. Ample literature suggests a possible role for vitamin D (VD) in influencing ASD clinical phenotypes. We analyzed three vitamin D binding protein gene (DBP) functional polymorphisms (rs2282679, rs7041, and rs4588), which are involved in the modulation of vitamin D serum concentration in 309 ASD children and 831 healthy controls. Frequency comparisons of single nucleotide polymorphisms (SNPs) alleles, genotypes, and GC isoforms (GC1f, G1s, and GC2)—generated by the combination of rs7041 and rs4588 alleles—were correlated with ASD diagnostic, behavioral, and functioning scales. The GC1f isoform was significantly more frequent in ASD compared with controls (18.6% vs. 14.5% pc = 0.02). Significantly higher scores for item 15 of the Childhood Autism Rating Scale (CARS) and lower ones for the Children’s Global Assessment Scale (CGAS) functioning scales were seen in ASD carrying the GC1f isoform. In GC phenotype analysis, a gradient of severity for overall CARS scores and CARS item 15 was observed, with scores decreasing according to the presence of GC1f-GC1f > GC1f-GC1s > GC1s-GC1s > GC1f-GC2 > GC2-GC2 isoforms. Similarly, lower CGAS scores were seen in carriers of the GC1f-GC1f isoform, whereas higher scores were present in those carrying GC2-GC2 (p = 0.028). This is the first study to evaluate possible relationships between GC variants and the different aspects of ASD in Italian ASD children. Results, although needing to be validated in ampler cohorts, suggest that the GC1f isoform could be a marker of severity in ASD that may be useful in establishing the intensity of therapeutic and rehabilitative protocols.

Impact Supplement of the Strengths and Difficulties Questionnaire in the Assessment of Functional Impairment in Children with ADHD or ASD in a Mixed Neuropediatric Sample: A Partial Validation Study

Background In addition to symptoms of neurodevelopmental disorders, functional impairment is crucial to the determination of clinical significance. The aim of this study was to examine partial validity and usefulness of the Strengths and Difficulties Questionnaire’s (SDQ) impact supplement (SDQ impact) in measuring functional impairment in children and adolescents diagnosed with attention deficit/hyperactivity disorder (ADHD) or autism spectrum disorder (ASD) in neuropediatric clinics. Methods Participants were children and adolescents (N = 337) referred to neuropediatric outpatient clinics for neurodevelopmental assessment. Functional impairment was evaluated using three instruments: the SDQ impact, the Vineland Adaptive Behavior Scale (VABS-II), and the Children’s Global Assessment Scale (CGAS). Mental health symptoms and intellectual function were also assessed. We investigated convergent and concurrent validity of the SDQ impact. Results The convergent validity of the SDQ impact was shown by its significant correlations with the VABS-II composite score and the CGAS total score. The concurrent validity of the SDQ impact was demonstrated by its significant relationship with ADHD and ASD diagnoses in logistic regression analyses. Using established cutoffs, the sensitivity of the SDQ impact to reveal functional impairment in children with ADHD and ASD diagnoses was demonstrated in this neuropediatric sample, but at the cost of low specificity. Conclusion The SDQ impact is an easy-to-use tool, and the overall study results indicate that it is partially valid, suggesting it may be used for the screening of general functional impairment in the neuropediatric population.

What Works for Whom? Differential Effects of Predictive Validity of Parenting Behaviours: Externalizing Versus Internalizing Behaviour Problems

A variety of instruments are available for assessing parental and child behaviour in the context of interaction observation. This study investigated whether the Laboratory Parenting Assessment Battery (Lab-PAB) can be used to make predictive statements about the therapeutic success of child psychiatric treatment. The success of therapy was measured through pre- and post-intervention assessments using the Child Behavior Checklist (CBCL) and the Parent-Infant Relationship Global Assessment Scale (PIR-GAS). A particular focus was placed on discriminating between externalizing and internalizing problems of the child. It was observed that positive items of the interaction offer a greater resource for the therapeutic success of children with externalizing problems than stopping negative behaviour of the parents. In the case of internalizing problems, the elimination of negative interaction items seems to be essential for a good therapy success.

Determination of key prognostic factors for the development of acne recurrence after systemic isotretinoin therapy

Since the 80s of the last century, the most effective drug for the treatment of acne is systemic isotretinoin (SI). The introduction of SI into practice makes it possible to achieve stable clinical remission or complete recovery in 80% of acne patients, regardless of the severity of the disease, however, 20% of patients may experience relapses in the next 1.52 years.&#x0D; Aim. To establish the factors determining the likelihood of acne recurrence after a course of therapy using the systemic isotrtinoin.&#x0D; Materials and methods. After examining 275 patients, 84 patients (50 women and 34 men) who had previously been treated with SI for acne took part in the study, 54 of them had relapses for at least 4 months and the comparison group consisted of 30 patients out of 221 surveyed who did not have relapses after treatment. As part of the study, a retrospective analysis of outpatient records was carried out, data on the history of life and illness, comorbid hormonal pathology in women, anthropometric characteristics were recorded, and the presence of heredity for acne was also taken into account, the severity of acne was assessed using the Investigator's Global Assessment scale; laboratory examination was performed to exclude insulin resistance.&#x0D; Results. The development of relapses after the first course of acne treatment using SI was registered in 19.63%, however, indications for a second course of treatment were stated in 12.00%. The analysis of the data obtained allowed us to determine the main factors that contributed to the development of relapses: severe acne severity, the presence of rashes on the trunk, body mass index more than 25, the presence of hormonal abnormalities in women, scarification, male sex, daily dose less than 0.5 mg/kg, the presence of heredity for acne in both parents, the course dose of SI120 mg/kg, insulin resistance.&#x0D; Conclusion. The issue of studying the factors that can cause the development of acne recurrence after the end of the course of therapy is an extremely urgent problem, due to the fact that taking them into account at the early stages of treatment of patients will increase the percentage of patients with complete clinical remission or recovery.

A network analysis of anxiety, depressive, and psychotic symptoms and functioning in children and adolescents at clinical high risk for psychosis.

Youths at clinical high risk for psychosis (CHR-P) are characterized by a high prevalence of anxiety and depressive disorders. The present study aimed at developing and analyzing a network structure of CHR-P symptom domains (i.e., positive, negative, disorganization, and general subclinical psychotic symptoms), depressive and anxiety symptoms, and general functioning. Network analysis was applied to data on 111 CHR-P children and adolescents (M age = 14.1), who were assessed using the Structured Interview for Prodromal Syndromes, the Children's Depression Inventory, the Children's Global Assessment Scale, and the Multidimensional Anxiety Scale for Children. In the network, negative and disorganization symptoms showed the strongest association (r = 0.71), and depressive and anxiety symptoms showed dense within-domain connections, with a main bridging role played by physical symptoms of anxiety. The positive symptom cluster was not associated with any other node. The network stability coefficient (CS) was slightly below 0.25, and observed correlations observed ranged from 0.35 to 0.71. The lack of association between subclinical positive symptoms and other network variables confirmed the independent nature of subclinical positive symptoms from comorbid symptoms, which were found to play a central role in the analyzed network. Complex interventions should be developed to target positive and comorbid symptoms, prioritizing those with the most significant impact on functioning and the most relevance for the young individual, through a shared decision-making process. Importantly, the results suggest that negative and disorganization symptoms, as well as depressive and anxiety symptoms, may be targeted simultaneously.

Efficacy and safety of methylphenidate and behavioural parent training for children aged 3–5 years with attention-deficit hyperactivity disorder: a randomised, double-blind, placebo-controlled, and sham behavioural parent training-controlled trial

There is insufficient evidence to support treatment recommendations for preschool children aged 3-5 years with attention-deficit hyperactivity disorder (ADHD). We aimed to investigate the efficacy and safety of methylphenidate and behavioural parent training in reducing the frequency and severity of symptoms and improving global functioning in preschool children with ADHD. We did an 8-week, randomised, double-blind, placebo-controlled and sham behavioural parent training-controlled clinical trial (the MAPPA Study) in children aged 3-5 years with moderate-to-severe ADHD. The trial was conducted at the Institute of Psychiatry, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, Brazil. Participants were randomly assigned (1:1:1) to receive immediate-release methylphenidate plus educational intervention (sham behavioural parent training), placebo medication plus behavioural parent training, or placebo medication plus educational intervention. Randomisation was done by an independent research manager by use of a permuted block randomisation procedure. Parents, teachers, study staff, and evaluators remained masked to group allocation. Methylphenidate and placebo were titrated to a maximum dose of 1·25 mg/kg per day administered orally twice daily, and behavioural parent training and the educational intervention were delivered weekly through 90 min sessions with both the child and parent, conducted by two psychologists or learning therapists. The primary outcomes were parents' and teachers' composite scores of the Swanson, Nolan, and Pelham-IV scale (SNAP-IV-P/T), the Clinical Global Impressions Severity (CGI-S) scale, and the Children's Global Assessment Scale (CGAS). This trial is registered with ClinicalTrials.gov, NCT02807870, and is now complete. All participants were invited to participate in an open observational follow-up, which is ongoing. Between Aug 21, 2016, and Oct 21, 2019, 153 children were randomly assigned to receive methylphenidate plus the educational intervention (n=51), placebo plus behavioural parent training (n=51), or placebo plus the educational intervention (n=51). Nine (6%) children discontinued treatment. All participants were included in the intention-to-treat analysis. Children in the methylphenidate plus educational intervention group showed greater reductions in the SNAP-IV-P/T (endpoint mean difference -3·93 [95% CI -7·14 to -0·73], p=0·049; effect size -0·55 [95% CI -0·99 to -0·10]) and CGI-S scores (endpoint mean difference -0·49 [-0·82 to -0·17], p=0·0088; effect size -0·70 [-1·16 to -0·24]) and a greater increase in CGAS scores (endpoint mean difference 5·25 [95% CI 2·09 to 8·40], p=0·0036; effect size 0·80 [95% CI 0·32 to 1·28]) than children in the placebo plus educational intervention group. Children in the placebo plus behavioural parent training group did not have significantly different SNAP-IV-P/T scores (endpoint mean difference -3·18 [95% CI -6·38 to 0·02], p=0·077; effect size -0·44 [95% CI -0·89 to 0·003]) or CGI-S scores (endpoint mean difference -0·35 [-0·68 to -0·03], p=0·052; effect size -0·50 [-0·96 to -0·04]) compared to children in the placebo plus educational intervention group, but they had a greater increase in CGAS scores compared to the placebo plus educational intervention group (endpoint mean difference 3·69 [0·53 to 6·85], p=0·033; effect size 0·56 [0·08 to 1·04]). Children in the methylphenidate plus educational intervention versus placebo plus behavioural parent training group did not have statistically or clinically significant differences in primary outcomes. Children in the methylphenidate plus educational intervention group had more mild adverse events than the other two groups, and there were no between-group differences for moderate or severe adverse events. Methylphenidate was effective in reducing ADHD symptoms and improving functionality, and behavioural parent training was effective in improving functionality for preschool children with ADHD after 8 weeks of treatment. São Paulo Research Foundation and Brazilian National Council for Scientific and Technological Development.

Comparisons of outcomes between different age groups attending a specialist mental health service for children and young people in care

Objective: Children and adolescents in care experience higher rates of mental illness. No studies have looked at differences in treatment effect amongst age groups for children/young people in care accessing mental health services. This study aims to determine if age is associated with outcomes for children and adolescents in care receiving treatment from a specialist mental health service in Queensland, Australia. Method: This 5-year retrospective cohort study consisted of a sample of 1338 children and adolescents in care aged 0–17 with pre- and post-treatment data. The Children’s Global Assessment Scale (CGAS) and the Health of the Nations Outcome Scale for Children and Adolescents (HoNOSCA) were used to assess functioning and mental health outcomes. Results: Data analysis revealed significant differences between the age groups. Age 0–4 also showed significantly greater improvement on a number of domains when compared with older age groups, including overactivity and attention, scholastic and language skills, emotional symptoms, peer relationships, and family life and relationships. Conclusion: This study demonstrated positive outcomes for all ages, yet better outcomes for the younger age groups in a cohort of children and adolescents in care attending a specialist mental health service. It highlights the importance of providing mental health interventions to children/young people in care, particularly age 0–4. Further, it calls for validated measures for young children to be utilised across mental health services to aid research in this area and optimise outcomes for this vulnerable population.

Early perioperative versus postoperative meloxicam for pain control in patients undergoing orthopedic surgery: a systematic review and meta-analysis of randomized controlled trials

Objective Post-orthopaedic operative pain is a serious concern that often requires the administration of analgesics; however, the optimal time of analgesic administration is still inconclusive. Perioperative analgesia is administrating pre-emptive analgesia before and during the surgery followed by postoperative analgesia to decrease the procedure associated nociceptive response. We aim to assess perioperative meloxicam versus postoperative meloxicam for pain control after orthopaedic operations. Methods A systematic review and meta-analysis involving randomized controlled trials from PubMed, Embase, Scopus, WOS, and CENTAL until May 28th, 2022. We pooled dichotomous outcomes using risk ratio (RR) presented with a 95% confidence interval (CI) and continuous outcomes using mean difference (MD) with 95% CI. We registered our protocol in PROSPERO with ID: CRD42022336046. Results We included five RCTs with 964 patients. All the included trials showed high risk of performance and detection biases because of lack of blinding. Pooled analysis favored perioperative meloxicam in reducing pain score after six hours (MD: -0.42 with 95% CI [-0.63, -0.21], p = 0.0001), 12 hours (MD: -0.54 with 95% CI [-0.69, -0.39], p = 0.00001), and 24 hours (MD: -0.23 with 95% CI [-0.36, -0.10]. Pooled analysis favored perioperative meloxicam in improving patient global assessment scale after 12 hours (MD: -0.66 with 95% CI [-0.86, -0.46], p = 0.00001), 24 hours (MD: -0.30 with 95% CI [-0.49, -0.11, p = 0.002), and 48 hours (MD: -0.17 with 95% CI [-0.33, -0.01], p = 0.04). Pooled analysis favored perioperative meloxicam in reducing patient-controlled analgesia (MD: -4.25 with 95% CI [-5.96, -2.54], p = 0.00001). Conclusion Short-term pain management after orthopaedic procedures is better accomplished with perioperative meloxicam than postoperative meloxicam. Before recommending perioperative meloxicam for pain control following orthopaedic surgeries, further multicentre trials are still warranted to examine the impact of perioperative meloxicam in different orthopaedic procedures.

Severity stages of chronic nodular prurigo: analysis of associated itch intensity and quality of life impairment

Introduction: Chronic nodular prurigo (CNPG) is a pruritic neuroinflammatory skin disease characterized by the presence of multiple pruriginous nodules. Previous psychometric analyzes showed the presence of moderate to severe pruritus and a considerable impairment of quality of life. A detailed study of these parameters in relation to the severity of the disease defined by the number of lesions is lacking. Methods: A total of 131 adult patients with CNPG were included. The number of pruriginous lesions and disease stage was determined by using the Prurigo Activity and Severity (PAS) scale and the prurigo-specific Investigator’s Global Assessment (IGA) scale. Patient-reported outcomes comprised pruritus intensity (worst itch intensity of the previous 24 h using the numerical rating scale; WI-NRS/24 h) and the impairment of quality of life (ItchyQol, Dermatology Life Quality Index; DLQI). Results: The counted and estimated number of pruriginous nodules correlated strongly with each other (r=0.82; P&lt;0.001), moderately with the WI-NRS/24 h (counted number: r=0.44, P&lt;0.001; estimated number: r=0.45, P&lt;0.001) and with the DLQI score (counted number: r=0.40, P&lt;0.001; estimated number: r=0.38, P&lt;0.001). The severity groups of the CNPG, as defined by the IGA scale, correlated strongly with the WINRS/24 h and DLQI scores. With increasing severity of CNPG, increasing pruritus intensity and DLQI/ItchyQoL scores were recorded. Conclusion: The correlation between objective (disease stage) and subjective (itch intensity, quality of life) CNPG disease parameters argues for a representative disease severity characterization via physician assessments using either PAS or IGA.