RESUMO
BACKGROUND: Several computerised cognitive tests (e.g. continuous performance test) have been developed to support the clinical assessment of attention-deficit/hyperactivity disorder (ADHD). Here, we appraised the evidence-base underpinning the use of one of these tests - the QbTest - in clinical practice, by conducting a systematic review and meta-analysis investigating its accuracy and clinical utility. METHODS: Based on a preregistered protocol (CRD42022377671), we searched PubMed, Medline, Ovid Embase, APA PsycINFO and Web of Science on 15th August 2022, with no language/type of document restrictions. We included studies reporting accuracy measures (e.g. sensitivity, specificity, or Area under the Receiver Operating Characteristics Curve, AUC) for QbTest in discriminating between people with and without DSM/ICD ADHD diagnosis. Risk of bias was assessed with the Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2). A generic inverse variance meta-analysis was conducted on AUC scores. Pooled sensitivity and specificity were calculated using a random-effects bivariate model in R. RESULTS: We included 15 studies (2,058 participants; 48.6% with ADHD). QbTest Total scores showed acceptable, rather than good, sensitivity (0.78 [95% confidence interval: 0.69; 0.85]) and specificity (0.70 [0.57; 0.81]), while subscales showed low-to-moderate sensitivity (ranging from 0.48 [0.35; 0.61] to 0.65 [0.52; 0.75]) and moderate-to-good specificity (from 0.65 [0.48; 0.78] to 0.83 [0.60; 0.94]). Pooled AUC scores suggested moderate-to-acceptable discriminative ability (Q-Total: 0.72 [0.57; 0.87]; Q-Activity: 0.67 [0.58; 0.77); Q-Inattention: 0.66 [0.59; 0.72]; Q-Impulsivity: 0.59 [0.53; 0.64]). CONCLUSIONS: When used on their own, QbTest scores available to clinicians are not sufficiently accurate in discriminating between ADHD and non-ADHD clinical cases. Therefore, the QbTest should not be used as stand-alone screening or diagnostic tool, or as a triage system for accepting individuals on the waiting-list for clinical services. However, when used as an adjunct to support a full clinical assessment, QbTest can produce efficiencies in the assessment pathway and reduce the time to diagnosis.
RESUMO
BACKGROUND: Little is known about the long-term effectiveness of behavioural therapy for tics. We aimed to assess the long-term clinical and cost-effectiveness of online therapist-supported exposure and response prevention (ERP) therapy for tics 12 and 18 months after treatment initiation. METHODS: ORBIT (online remote behavioural intervention for tics) was a two-arm (1:1 ratio), superiority, single-blind, multicentre randomised controlled trial comparing online ERP for tics with online psychoeducation. The trial was conducted across two Child and Adolescent Mental Health Services in England. Participants were recruited from these two sites, across other clinics in England, or by self-referral. This study was a naturalistic follow-up of participants at 12- and 18-month postrandomisation. Participants were permitted to use alternative treatments recommended by their clinician. The key outcome was the Yale Global Tic Severity Scale Total Tic Severity Score (YGTSS-TTSS). A full economic evaluation was conducted. Registrations are ISRCTN (ISRCTN70758207); ClinicalTrials.gov (NCT03483493). RESULTS: Two hundred and twenty-four participants were enrolled: 112 to ERP and 112 to psychoeducation. The sample was predominately male (177; 79%) and of white ethnicity (195; 87%). The ERP intervention reduced baseline YGTSS-TTSS by 2.64 points (95% CI: -4.48 to -0.79) with an effect size of -0.36 (95% CI: -0.61 to -0.11) after 12 months and by 2.01 points (95% CI: -3.86 to -0.15) with an effect size of -0.27 (95% CI -0.52 to -0.02) after 18 months, compared with psychoeducation. Very few participants (<10%) started new tic treatment during follow-up. The cost difference in ERP compared with psychoeducation was £304.94 (-139.41 to 749.29). At 18 months, the cost per QALY gained was £16,708 for ERP compared with psychoeducation. CONCLUSIONS: Remotely delivered online ERP is a clinical and cost-effective intervention with durable benefits extending for up to 18 months. This represents an efficient public mental health approach to increase access to behavioural therapy and improve outcomes for tics.
Assuntos
Transtornos de Tique , Tiques , Humanos , Masculino , Criança , Adolescente , Tiques/terapia , Análise Custo-Benefício , Seguimentos , Método Simples-CegoRESUMO
ADHD is the most common neurodevelopmental disorder presenting to child and adolescent mental health, paediatric, and primary care services. Timely and effective interventions to address core ADHD symptoms and co-occurring problems are a high priority for healthcare and society more widely. While much research has reported on the benefits and adverse effects of different interventions for ADHD, these individual research reports and the reviews, meta-analyses and guidelines summarizing their findings are sometimes inconsistent and difficult to interpret. We have summarized the current evidence and identified several methodological issues and gaps in the current evidence that we believe are important for clinicians to consider when evaluating the evidence and making treatment decisions. These include understanding potential impact of bias such as inadequate blinding and selection bias on study outcomes; the relative lack of high-quality data comparing different treatments and assessing long-term effectiveness, adverse effects and safety for both pharmacological and non-pharmacological treatments; and the problems associated with observational studies, including those based on large national registries and comparing treatments with each other. We highlight key similarities across current international clinical guidelines and discuss the reasons for divergence where these occur. We discuss the integration of these different perspective into a framework for person/family-centered evidence-based practice approach to care that aims to achieve optimal outcomes that prioritize individual strengths and impairments, as well as the personal treatment targets of children and their families. Finally, we consider how access to care for this common and impairing disorder can be improved in different healthcare systems.
Assuntos
Transtorno do Deficit de Atenção com Hiperatividade , Criança , Humanos , Adolescente , Transtorno do Deficit de Atenção com Hiperatividade/terapia , Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Saúde Mental , Instituições de Assistência AmbulatorialRESUMO
To understand how children and young people with tic disorders were affected by COVID-19, we compared pre and during pandemic scores on the Yale Global Tic Severity Scale (YGTSS). Participants were young people (N = 112; male:78%; 9-17 years) randomised to the control arm of the "ORBIT-Trial" (ISRCTN70758207, ClinicalTrials.gov-NCT03483493). For this analysis, the control arm was split into two groups: one group was followed up to 12-months' post-randomisation before the pandemic started (pre-COVID group, n = 44); the other group was impacted by the pandemic at the 12-month follow-up (during-COVID group, n = 47). Mixed effects linear regression modelling was conducted to explore differences in YGTSS at 6- and 12-months post-randomisation. There were no significant differences in tic symptom or severity between participants who were assessed before and during COVID-19. This finding was not influenced by age, gender, symptoms of anxiety or autism spectrum disorder. Thus, the COVID-19 pandemic did not significantly impact existing tic symptoms.
Assuntos
Transtorno do Espectro Autista , COVID-19 , Transtornos de Tique , Tiques , Síndrome de Tourette , Masculino , Humanos , Criança , Adolescente , Pandemias , Estudos Prospectivos , Índice de Gravidade de Doença , COVID-19/epidemiologia , Transtornos de Tique/diagnóstico , Transtornos de Tique/epidemiologiaRESUMO
BACKGROUND: Studies have reported an increased risk of mortality among people prescribed mirtazapine compared to other antidepressants. The study aimed to compare all-cause and cause-specific mortality between adults prescribed mirtazapine or other second-line antidepressants. METHODS: This cohort study used English primary care electronic medical records, hospital admission records, and mortality data from the Clinical Practice Research Datalink (CPRD), for the period 01 January 2005 to 30 November 2018. It included people aged 18-99 years with depression first prescribed a selective serotonin reuptake inhibitor (SSRI) and then prescribed mirtazapine (5081), a different SSRI (15,032), amitriptyline (3905), or venlafaxine (1580). Follow-up was from starting to stopping the second antidepressant, with a 6-month wash-out window, censoring at the end of CPRD follow-up or 30 November 2018. Age-sex standardised rates of all-cause mortality and death due to circulatory system disease, cancer, or respiratory system disease were calculated. Survival analyses were performed, accounting for baseline characteristics using inverse probability of treatment weighting. RESULTS: The cohort contained 25,598 people (median age 41 years). The mirtazapine group had the highest standardised mortality rate, with an additional 7.8 (95% confidence interval (CI) 5.9-9.7) deaths/1000 person-years compared to the SSRI group. Within 2 years of follow-up, the risk of all-cause mortality was statistically significantly higher in the mirtazapine group than in the SSRI group (weighted hazard ratio (HR) 1.62, 95% CI 1.28-2.06). No significant difference was found between the mirtazapine group and the amitriptyline (HR 1.18, 95% CI 0.85-1.63) or venlafaxine (HR 1.11, 95% CI 0.60-2.05) groups. After 2 years, the risk was significantly higher in the mirtazapine group compared to the SSRI (HR 1.51, 95% CI 1.04-2.19), amitriptyline (HR 2.59, 95% CI 1.38-4.86), and venlafaxine (HR 2.35, 95% CI 1.02-5.44) groups. The risks of death due to cancer (HR 1.74, 95% CI 1.06-2.85) and respiratory system disease (HR 1.72, 95% CI 1.07-2.77) were significantly higher in the mirtazapine than in the SSRI group. CONCLUSIONS: Mortality was higher in people prescribed mirtazapine than people prescribed a second SSRI, possibly reflecting residual differences in other risk factors between the groups. Identifying these potential health risks when prescribing mirtazapine may help reduce the risk of mortality.
Assuntos
Antidepressivos , Registros Eletrônicos de Saúde , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antidepressivos/uso terapêutico , Causas de Morte , Estudos de Coortes , Humanos , Pessoa de Meia-Idade , Mirtazapina/uso terapêutico , Adulto JovemRESUMO
BACKGROUND: The Online Remote Behavioral Intervention for Tics (ORBIT) study was a multicenter randomized controlled trial of a complex intervention that consisted of a web-based behavioral intervention for children and young people with tic disorders. In the first part of a two-stage process evaluation, we conducted a mixed methods study exploring the reach, dose, and fidelity of the intervention and contextual factors influencing engagement. OBJECTIVE: This study aims to explore the fidelity of delivery and contextual factors underpinning the ORBIT trial. METHODS: Baseline study data and intervention usage metrics from participants in the intervention arm were used as quantitative implementation data (N=112). The experiences of being in the intervention were explored through semistructured interviews with children (n=20) and parent participants (n=20), therapists (n=4), and referring clinicians (n=6). A principal component analysis was used to create a comprehensive, composite measure of children and young people's engagement with the intervention. Engagement factor scores reflected relative uptake as assessed by a range of usage indices, including chapters accessed, number of pages visited, and number of log-ins. The engagement factor score was used as the dependent variable in a multiple linear regression analysis with various contextual variables as independent variables to assess if there were any significant predictors of engagement. RESULTS: The intervention was implemented with high fidelity, and participants deemed the intervention acceptable and satisfactory. The engagement was high, with child participants completing an average of 7.5 of 10 (SD 2.7) chapters, and 88.4% (99/112) of participants completed the minimum of the first four chapters-the predefined threshold effective dose. Compared with the total population of children with tic disorders, participants in the sample tended to have more educated parents and lived in more economically advantaged areas; however, socioeconomic factors were not related to engagement factor scores. Factors associated with higher engagement factor scores included participants enrolled at the London site versus the Nottingham site (P=.01), self-referred versus clinic referred (P=.04), higher parental engagement as evidenced by the number of parental chapters completed (n=111; ρ=0.73; P<.001), and more therapist time for parents (n=111; ρ=0.46; P<.001). A multiple linear regression indicated that parents' chapter completion (ß=.69; t110=10.18; P<.001) and therapist time for parents (ß=.19; t110=2.95; P=.004) were the only significant independent predictors of child engagement factor scores. CONCLUSIONS: Overall, the intervention had high fidelity of delivery and was evaluated positively by participants, although reach may have been constrained by the nature of the randomized controlled trial. Parental engagement and therapist time for parents were strong predictors of intervention implementation, which has important implications for designing and implementing digital therapeutic interventions in child and adolescent mental health services. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-019-3974-3.
Assuntos
Intervenção Baseada em Internet , Transtornos de Tique , Tiques , Adolescente , Terapia Comportamental , Criança , Humanos , PaisRESUMO
BACKGROUND: In response to COVID-19, there has been increasing momentum in telehealth development and delivery. To assess the anticipated exponential growth in telehealth, it is important to accurately capture how telehealth has been used in specific mental health fields prior to the pandemic. OBJECTIVE: This systematic review aimed to highlight how telehealth has been used with clinical samples in the neurodevelopmental field, including patients with neurodevelopmental disorders (NDDs), their families, and health care professionals. To identify which technologies show the greatest potential for implementation into health services, we evaluated technologies for effectiveness, economic impact, and readiness for clinical adoption. METHODS: A systematic search of literature was undertaken in April 2018 and updated until December 2019, by using the Medline, Web of Science, Scopus, CINAHL Plus, EMBASE, and PsycInfo databases. Extracted data included the type of technology, how the technology was used (ie, assessment, treatment, and monitoring), participant characteristics, reported outcomes and authors' views on clinical effectiveness, user impact (ie, feasibility and acceptability), economic impact, and readiness for clinic adoption. A quality review of the research was performed in accordance with the Oxford Centre for Evidence-Based Medicine Levels of Evidence. RESULTS: A total of 42 studies met the inclusion criteria. These studies included participants and family members with autism spectrum disorders (21/42, 50%), attention deficit hyperactivity disorders (8/42, 19%), attention deficit hyperactivity or autism spectrum disorders (3/42, 7%), communication disorders (7/42, 17%), and tic disorders (2/42, 5%). The focus of most studies (33/42, 79%) was on treatment, rather than assessment (4/42, 10%) or monitoring (5/42, 12%). Telehealth services demonstrated promise for being clinically effective, predominantly in relation to diagnosing and monitoring NDDs. In terms of NDD treatment, telehealth services were usually equivalent to control groups. There was some evidence of positive user and economic impacts, including increased service delivery efficiency (eg, increased treatment availability and decreased waiting times). However, these factors were not widely recorded across the studies. Telehealth was demonstrated to be cost-effective in the few studies that considered cost-effectiveness. Study quality varied, as many studies had small sample sizes and inadequate control groups. Of the 42 studies, only 11 (26%) were randomized controlled trials, 12 (29%) were case studies or case series, 6 (14%) were qualitative studies, and 5 (12%) were noncomparative trials. CONCLUSIONS: Telehealth has the potential to increase treatment availability, decrease diagnosis waiting times, and aid in NDD monitoring. Further research with more robust and adequately powered study designs that consider cost-effectiveness and increased efficiency is needed. This systematic review highlights the extent of telehealth technology use prior to the COVID-19 pandemic and the movement for investing in remote access to treatments. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42018091156; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42018091156.
Assuntos
Monitorização Fisiológica/métodos , Transtornos do Neurodesenvolvimento/terapia , Telemedicina/métodos , Feminino , Humanos , Masculino , Transtornos do Neurodesenvolvimento/epidemiologia , Pesquisa QualitativaRESUMO
BACKGROUND: The use of antidepressants in children and adolescents remains controversial. We examined trends over time and variation in antidepressant prescribing in children and young people in England and whether the drugs prescribed reflected UK licensing and guidelines. METHODS AND FINDINGS: QResearch is a primary care database containing anonymised healthcare records of over 32 million patients from more than 1,500 general practices across the UK. All eligible children and young people aged 5-17 years in 1998-2017 from QResearch were included. Incidence and prevalence rates of antidepressant prescriptions in each year were calculated overall, for 4 antidepressant classes (selective serotonin reuptake inhibitors [SSRIs], tricyclic and related antidepressants [TCAs], serotonin and norepinephrine reuptake inhibitors [SNRIs], and other antidepressants), and for individual drugs. Adjusted trends over time and differences by social deprivation, region, and ethnicity were examined using Poisson regression, taking clustering within general practitioner (GP) practices into account using multilevel modelling. Of the 4.3 million children and young people in the cohort, 49,434 (1.1%) were prescribed antidepressants for the first time during 20 million years of follow-up. Males made up 52.0% of the cohorts, but only 34.1% of those who were first prescribed an antidepressant in the study period. The largest proportion of the cohort was from London (24.4%), and whilst ethnicity information was missing for 39.5% of the cohort, of those with known ethnicity, 75.3% were White. Overall, SSRIs (62.6%) were the most commonly prescribed first antidepressant, followed by TCAs (35.7%). Incident antidepressant prescribing decreased in 5- to 11-year-olds from a peak of 0.9 in females and 1.6 in males in 1999 to less than 0.2 per 1,000 for both sexes in 2017, but incidence rates more than doubled in 12- to 17-year-olds between 2005 and 2017 to 9.7 (females) and 4.2 (males) per 1,000 person-years. The lowest prescription incidence rates were in London, and the highest were in the South East of England (excluding London) for all sex and age groups. Those living in more deprived areas were more likely to be prescribed antidepressants after adjusting for region. The strongest trend was seen in 12- to 17-year-old females (adjusted incidence rate ratio [aIRR] 1.12, 95% confidence interval [95% CI] 1.11-1.13, p < 0.001, per deprivation quintile increase). Prescribing rates were highest in White and lowest in Black adolescents (aIRR 0.32, 95% CI 0.29-0.36, p < 0.001 [females]; aIRR 0.32, 95% CI 0.27-0.38, p < 0.001 [males]). The 5 most commonly prescribed antidepressants were either licensed in the UK for use in children and young people (CYP) or included in national guidelines. Limitations of the study are that, because we did not have access to secondary care prescribing information, we may be underestimating the prevalence and misidentifying the first antidepressant prescription. We could not assess whether antidepressants were dispensed or taken. CONCLUSIONS: Our analysis provides evidence of a continuing rise of antidepressant prescribing in adolescents aged 12-17 years since 2005, driven by SSRI prescriptions, but a decrease in children aged 5-11 years. The variation in prescribing by deprivation, region, and ethnicity could represent inequities. Future research should examine whether prescribing trends and variation are due to true differences in need and risk factors, access to diagnosis or treatment, prescribing behaviour, or young people's help-seeking behaviour.
Assuntos
Antidepressivos/uso terapêutico , Prescrições de Medicamentos/estatística & dados numéricos , Atenção Primária à Saúde/estatística & dados numéricos , Adolescente , Antidepressivos/farmacologia , Criança , Pré-Escolar , Estudos de Coortes , Transtorno Depressivo/tratamento farmacológico , Transtorno Depressivo/epidemiologia , Inglaterra/epidemiologia , Feminino , Humanos , Incidência , Masculino , Prevalência , Inibidores Seletivos de Recaptação de Serotonina/uso terapêuticoRESUMO
BACKGROUND: Antidepressants may be used to manage a number of conditions in children and young people including depression, anxiety, and obsessive-compulsive disorder. UK guidelines for the treatment of depression in children and young people recommend that antidepressants should only be initiated following assessment and diagnosis by a child and adolescent psychiatrist. The aim of this study was to summarise visits to mental health specialists and indications recorded around the time of antidepressant initiation in children and young people in UK primary care. METHODS: The study used linked English primary care electronic health records and Hospital Episode Statistics secondary care data. The study included 5-17-year-olds first prescribed antidepressants between January 2006 and December 2017. Records of visits to paediatric or psychiatric specialists and potential indications (from a pre-specified list) were extracted. Events were counted if recorded less than 12 months before or 6 months after the first antidepressant prescription. Results were stratified by first antidepressant type (all, selective serotonin reuptake inhibitors (SSRIs), tricyclic and related antidepressants) and by age group (5-11 years, 12-17 years). RESULTS: In total, 33,031 5-17-year-olds were included. Of these, 12,149 (37%) had a record of visiting a paediatrician or a psychiatric specialist in the specified time window. The majority of recorded visits (7154, 22%) were to paediatricians. Of those prescribed SSRIs, 5463/22,130 (25%) had a record of visiting a child and adolescent psychiatrist. Overall, 17,972 (54%) patients had a record of at least one of the pre-specified indications. Depression was the most frequently recorded indication (12,501, 38%), followed by anxiety (4155, 13%). CONCLUSIONS: The results suggest many children and young people are being prescribed antidepressants without the recommended involvement of a relevant specialist. These findings may justify both greater training for GPs in child and adolescent mental health and greater access to specialist care and non-pharmacological treatments. Further research is needed to explore factors that influence how and why GPs prescribe antidepressants to children and young people and the real-world practice barriers to adherence to clinical guidelines.
Assuntos
Antidepressivos/uso terapêutico , Atenção Primária à Saúde/estatística & dados numéricos , Atenção Secundária à Saúde/estatística & dados numéricos , Especialização/estatística & dados numéricos , Adolescente , Antidepressivos/farmacologia , Criança , Bases de Dados Factuais , Feminino , Humanos , Masculino , Projetos de PesquisaRESUMO
The rapid expansion of access to, and engagement with, the Internet and digital technology over the past 15 or so years has transformed the social, educational and therapeutic space occupied by children and young people in contemporary society in remarkable ways. First, it has created previously unimaginable opportunities for learning and development and personal exploration and growth. Second, it seems that the very same qualities and characteristics of the Internet that make these positive contributions possible, such as its immediacy, portability, intimacy, unconstrained reach and lack of supervision and regulation of content, has opened children and young people up to a range of serious social, intellectual and mental health risks. Finally, over and above these 'effects', the digital space is increasingly successfully being harnessed for the identification and treatment of mental health problems. Accordingly, the Internet is not so much a double-, as a triple-edged sword, with regard to children's mental health.
Assuntos
Tecnologia Digital , Saúde Mental , Adolescente , Criança , HumanosRESUMO
BACKGROUND: Remote measurement technologies (RMT) can be used to collect data on a variety of bio-behavioral variables, which may improve the care of patients with central nervous system disorders. Although various studies have explored their potential, prior work has highlighted a knowledge gap in health care professionals' (HCPs) perceptions of the value of RMT in clinical practice. OBJECTIVE: This study aims to understand HCPs' perspectives on using RMT in health care practice for the care of patients with depression, epilepsy, or multiple sclerosis (MS). METHODS: Semistructured interviews were conducted with 26 multidisciplinary primary and secondary care HCPs who care for patients with epilepsy, depression, or MS. Interviews were transcribed verbatim and analyzed using thematic analysis. RESULTS: A total of 8 main themes emerged from the analysis: (1) potential clinical value of RMT data; (2) when to use RMT in care pathways; (3) roles of health care staff who may use RMT data; (4) presentation and accessibility of data; (5) obstacles to successful use of RMT; (6) limits to the role of RMT; (7) empowering patients; and (8) considerations around alert-based systems. CONCLUSIONS: RMT could add value to the system of care for patients with central nervous system disorders by providing clinicians with graphic summaries of data in the patient record. Barriers of both technical and human nature should be considered when using these technologies, as should the limits to the benefits they can offer.
Assuntos
Doenças do Sistema Nervoso Central/terapia , Pessoal de Saúde/normas , Consulta Remota/métodos , Feminino , Humanos , Entrevista Psicológica , Masculino , Pesquisa Qualitativa , TecnologiaRESUMO
BACKGROUND: The study design and protocol that underpin a randomised controlled trial (RCT) are critical for the ultimate success of the trial. Although RCTs are considered the gold standard for research, there are multiple threats to their validity such as participant recruitment and retention, identifying a meaningful change, and non-adherence to the protocol. For clinical RCTs, involving patients and clinicians in protocol design provides the opportunity to develop research protocols that are meaningful to their target audience and may help overcome some of the inherent threats in conducting RCTs. However, the majority of protocols do not describe the methodology underpinning their development, limiting the amount of learned experience shared between research groups. METHOD: With the purpose of reporting a collaborative approach towards developing a protocol, we present the findings from three sequential workshops that were conducted with the aim of developing a protocol to investigate the feasibility of adding a computerised test of attention, impulsivity and activity (QbTest) to medication management of children and young people with Attention deficit hyperactivity disorder (ADHD). Based on previous qualitative interviews with clinicians and families, each workshop prioritised topics for focused discussion. Information from the workshops was fed back to the participants for reflection in advance of the next workshop. RESULTS: The workshops involved 21 multi-disciplinary ADHD experts, including clinicians, patient and public involvement (PPI) members, parents of young people with ADHD and researchers. The consensus workshops addressed key research issues such as: the most relevant outcome measures/ resource drivers; methods and time points for data collection; and the clinical protocol for utilising the QbTest, including when best to use this within the medication management process. The resulting protocol details a feasibility RCT design describing these factors. CONCLUSION: Protocols which are co-developed may help overcome some of the risks associated with RCT completion (e.g. recruitment, retention, protocol adherence) and help prioritise outcomes of greater relevance to the populations under study. The methodology has potential value for researchers and organisations developing clinical guidelines, and offers insights into the valuable impact of PPI upon trial design. TRIAL REGISTRATION: Clinicaltrials.gov NCT03368573, 11th December 2017 (retrospectively registered).
Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Protocolos Clínicos/normas , Conferências de Consenso como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa/normas , Adolescente , Criança , Feminino , Humanos , Masculino , Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Guias de Prática Clínica como Assunto/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Projetos de Pesquisa/estatística & dados numéricosRESUMO
BACKGROUND: The prevalence of certain neurodevelopmental disorders, specifically autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD), has been increasing over the last four decades. Nonpharmacological interventions are available that can improve outcomes and reduce associated symptoms such as anxiety, but these are often difficult to access. Children and young people are using the internet and digital technology at higher rates than any other demographic, but although Web-based interventions have the potential to improve health outcomes in those with long-term conditions, no previous reviews have investigated the effectiveness of Web-based interventions delivered to children and young people with neurodevelopmental disorders. OBJECTIVE: This study aimed to review the effectiveness of randomized controlled trials (RCTs) of Web-based interventions delivered to children and young people with neurodevelopmental disorders. METHODS: Six databases and one trial register were searched in August and September 2018. RCTs were included if they were published in a peer-reviewed journal. Interventions were included if they (1) aimed to improve the diagnostic symptomology of the targeted neurodevelopmental disorder or associated psychological symptoms as measured by a valid and reliable outcome measure; (2) were delivered on the Web; (3) targeted a youth population (aged ≤18 years or reported a mean age of ≤18 years) with a diagnosis or suspected diagnosis of a neurodevelopmental disorder. Methodological quality was rated using the Joanna Briggs Institute Critical Appraisal Checklist for RCTs. RESULTS: Of 5140 studies retrieved, 10 fulfilled the inclusion criteria. Half of the interventions were delivered to children and young people with ASDs with the other five targeting ADHD, tic disorder, dyscalculia, and specific learning disorder. In total, 6 of the 10 trials found that a Web-based intervention was effective in improving condition-specific outcomes or reducing comorbid psychological symptoms in children and young people. The 4 trials that failed to find an effect were all delivered by apps. The meta-analysis was conducted on five of the trials and did not show a significant effect, with a high level of heterogeneity detected (n=182 [33.4%, 182/545], 5 RCTs; pooled standardized mean difference=-0.39; 95% CI -0.98 to 0.20; Z=-1.29; P=.19 [I2=72%; P=.006]). CONCLUSIONS: Web-based interventions can be effective in reducing symptoms in children and young people with neurodevelopmental disorders; however, caution should be taken when interpreting these findings owing to methodological limitations, the minimal number of papers retrieved, and small samples of included studies. Overall, the number of studies was small and mainly limited to ASD, thus restricting the generalizability of the findings. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews: CRD42018108824; http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018108824.
Assuntos
Intervenção Baseada em Internet/tendências , Transtornos do Neurodesenvolvimento/terapia , Adolescente , Criança , Pré-Escolar , Feminino , HumanosRESUMO
BACKGROUND: Diagnosis of attention deficit hyperactivity disorder (ADHD) relies on subjective methods which can lead to diagnostic uncertainty and delay. This trial evaluated the impact of providing a computerised test of attention and activity (QbTest) report on the speed and accuracy of diagnostic decision-making in children with suspected ADHD. METHODS: Randomised, parallel, single-blind controlled trial in mental health and community paediatric clinics in England. Participants were 6-17 years-old and referred for ADHD diagnostic assessment; all underwent assessment-as-usual, plus QbTest. Participants and their clinician were randomised to either receive the QbTest report immediately (QbOpen group) or the report was withheld (QbBlind group). The primary outcome was number of consultations until a diagnostic decision confirming/excluding ADHD within 6-months from baseline. Health economic cost-effectiveness and cost utility analysis was conducted. Assessing QbTest Utility in ADHD: A Randomised Controlled Trial was registered at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02209116). RESULTS: One hundred and thirty-two participants were randomised to QbOpen group (123 analysed) and 135 to QbBlind group (127 analysed). Clinicians with access to the QbTest report (QbOpen) were more likely to reach a diagnostic decision about ADHD (hazard ratio 1.44, 95% CI 1.04-2.01). At 6-months, 76% of those with a QbTest report had received a diagnostic decision, compared with 50% without. QbTest reduced appointment length by 15% (time ratio 0.85, 95% CI 0.77-0.93), increased clinicians' confidence in their diagnostic decisions (odds ratio 1.77, 95% CI 1.09-2.89) and doubled the likelihood of excluding ADHD. There was no difference in diagnostic accuracy. Health economic analysis showed a position of strict dominance; however, cost savings were small suggesting that the impact of providing the QbTest report within this trial can best be viewed as 'cost neutral'. CONCLUSIONS: QbTest may increase the efficiency of ADHD assessment pathway allowing greater patient throughput with clinicians reaching diagnostic decisions faster without compromising diagnostic accuracy.
Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/diagnóstico , Atenção , Diagnóstico por Computador/métodos , Atividade Motora , Adolescente , Transtorno do Deficit de Atenção com Hiperatividade/psicologia , Criança , Análise Custo-Benefício , Tomada de Decisões Assistida por Computador , Feminino , Humanos , Masculino , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Método Simples-CegoRESUMO
The JCPP works at the cutting edge of clinical science to publish ground-breaking research across the full range of topics in the field of child psychology and psychiatry. As JCPP editors, who are also active researchers in our own right, we are conscious of the threat posed to our field by what has come to be known as the reproducibility crisis - the fact that many published findings, initially trumpeted as important developments in the field, cannot be replicated and are therefore likely to be spurious (Nature Human Behaviour, 1, 2017, 21). The JCPP is conscious of its responsibility to play its part in addressing this issue as best it can. The roots of the problem are complex and its causes multifaceted. As one part of its response, the JCPP embraces the principles of open science and encourage preregistration of study protocols. Furthermore, we are working towards implementing new systems to promote preregistration with the hope of increasing scientific transparency and accountability and reducing the risks of selective reporting and posthoc rationalisation of findings (Journal of Child Psychology & Psychiatry, 59, 2018, 1).
Assuntos
Pesquisa Biomédica/normas , Protocolos Clínicos/normas , Estudos Clínicos como Assunto/normas , Publicações Periódicas como Assunto , HumanosRESUMO
BACKGROUND: Behavioural interventions are recommended for use with children and young people with attention deficit hyperactivity disorder (ADHD); however, specific guidance for their implementation based on the best available evidence is currently lacking. METHODS: This review used an explicit question and answer format to address issues of clinical concern, based on expert interpretation of the evidence with precedence given to meta-analyses of randomised controlled trials. RESULTS: On the basis of current evidence that takes into account whether outcomes are blinded, behavioural intervention cannot be supported as a front-line treatment for core ADHD symptoms. There is, however, evidence from measures that are probably blinded that these interventions benefit parenting practices and improve conduct problems which commonly co-occur with ADHD, and are often the main reason for referral. Initial positive results have also been found in relation to parental knowledge, children's emotional, social and academic functioning - although most studies have not used blinded outcomes. Generic and specialised ADHD parent training approaches - delivered either individually or in groups - have reported beneficial effects. High-quality training, supervision of therapists and practice with the child, may improve outcomes but further evidence is required. Evidence for who benefits the most from behavioural interventions is scant. There is no evidence to limit behavioural treatments to parents with parenting difficulties or children with conduct problems. There are positive effects of additive school-based intervention for the inattentive subtype. Targeting parental depression may enhance the effects of behavioural interventions. CONCLUSIONS: Parent training is an important part of the multimodal treatment of children with ADHD, which improves parenting, reduces levels of oppositional and noncompliant behaviours and may improve other aspects of functioning. However, blinded evidence does not support it as a specific treatment for core ADHD symptoms. More research is required to understand how to optimise treatment effectiveness either in general or for individual patients and explore potential barriers to treatment uptake and engagement. In terms of selecting which intervention formats to use, it seems important to acknowledge and respond to parental treatment preferences.
Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/terapia , Terapia Comportamental , Educação não Profissionalizante , Pais , HumanosRESUMO
BACKGROUND: Concerns have been raised over the safety of methylphenidate (MPH), with regard to adverse effects on growth and blood pressure. Our study investigates whether, and to what extent, methylphenidate use in boys with ADHD is associated with having low body mass index (BMI), having low height, and increased systolic and diastolic blood pressure. METHODS: Data used for this study stem from the German KiGGS dataset. Three different groups of boys aged 6-15 years were included in the analysis: ADHD patients who used MPH for less than 12 months; ADHD patients who used MPH for 12 months or more; and ADHD patients without current MPH treatment. Each of these three groups was compared to a non-ADHD control group regarding low weight (BMI ≤ 3rd percentile), low height (≤3rd percentile) and raised systolic and diastolic blood pressure. For growth outcomes, boys were categorized according to age (< 11 years/≥11 years, to account for pubertal maturation). Multivariable logistic regression was conducted to test for associations. RESULTS: 4244 boys were included in the study; MPH < 12 months: n = 65 (n = 36 < 11 years), MPH ≥ 12 months: n = 53 (n = 22 < 11 years), ADHD controls: n = 320 (n = 132 < 11 years), non-ADHD controls: n = 3806 (n = 2003 < 11 years). Pre-pubertal boys with MPH use less than 12 months and pubertal/postpubertal boys with MPH use of 12 months or greater were significantly more likely to have a BMI ≤ 3rd percentile compared to non-ADHD controls. Boys from the ADHD control group were significantly less likely to have a raised systolic blood pressure compared to non-ADHD controls. Beyond that, no significant between group differences were observed for any other growth and BP parameter. CONCLUSION: The analyses of the KiGGS dataset showed that MPH use in boys with ADHD is associated with low BMI. However, this effect was only observed in certain groups. Furthermore, our analysis was unable to confirm that MPH use is also associated with low height (≤3rd percentile) and changes in blood pressure.
Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Pressão Sanguínea/efeitos dos fármacos , Estatura/efeitos dos fármacos , Estimulantes do Sistema Nervoso Central/administração & dosagem , Inquéritos Epidemiológicos/métodos , Metilfenidato/administração & dosagem , Adolescente , Transtorno do Deficit de Atenção com Hiperatividade/epidemiologia , Pressão Sanguínea/fisiologia , Estatura/fisiologia , Índice de Massa Corporal , Criança , Estudos de Coortes , Estudos Transversais , Esquema de Medicação , Alemanha/epidemiologia , Humanos , Masculino , Resultado do Tratamento , Redução de Peso/efeitos dos fármacos , Redução de Peso/fisiologiaRESUMO
BACKGROUND: Digital health interventions (DHIs), including computer-assisted therapy, smartphone apps and wearable technologies, are heralded as having enormous potential to improve uptake and accessibility, efficiency, clinical effectiveness and personalisation of mental health interventions. It is generally assumed that DHIs will be preferred by children and young people (CYP) given their ubiquitous digital activity. However, it remains uncertain whether: DHIs for CYP are clinically and cost-effective, CYP prefer DHIs to traditional services, DHIs widen access and how they should be evaluated and adopted by mental health services. This review evaluates the evidence-base for DHIs and considers the key research questions and approaches to evaluation and implementation. METHODS: We conducted a meta-review of scoping, narrative, systematic or meta-analytical reviews investigating the effectiveness of DHIs for mental health problems in CYP. We also updated a systematic review of randomised controlled trials (RCTs) of DHIs for CYP published in the last 3 years. RESULTS: Twenty-one reviews were included in the meta-review. The findings provide some support for the clinical benefit of DHIs, particularly computerised cognitive behavioural therapy (cCBT), for depression and anxiety in adolescents and young adults. The systematic review identified 30 new RCTs evaluating DHIs for attention deficit/hyperactivity disorder (ADHD), autism, anxiety, depression, psychosis, eating disorders and PTSD. The benefits of DHIs in managing ADHD, autism, psychosis and eating disorders are uncertain, and evidence is lacking regarding the cost-effectiveness of DHIs. CONCLUSIONS: Key methodological limitations make it difficult to draw definitive conclusions from existing clinical trials of DHIs. Issues include variable uptake and engagement with DHIs, lack of an agreed typology/taxonomy for DHIs, small sample sizes, lack of blinded outcome assessment, combining different comparators, short-term follow-up and poor specification of the level of human support. Research and practice recommendations are presented that address the key research questions and methodological issues for the evaluation and clinical implementation of DHIs for CYP.
Assuntos
Transtornos Mentais/terapia , Telemedicina/métodos , Terapia Assistida por Computador/métodos , Adolescente , Adulto , Criança , Pré-Escolar , Humanos , Adulto JovemRESUMO
BACKGROUND: The diagnosis and monitoring of Attention deficit hyperactivity disorder (ADHD) typically relies on subjective reports and observations. Objective continuous performance tests (CPTs) have been incorporated into some services to support clinical decision making. However, the feasibility and acceptability of adding such a test into routine practice is unknown. The study aimed to investigate the feasibility and acceptability of adding an objective computerised test to the routine assessment and monitoring of attention deficit hyperactivity disorder (ADHD). METHODS: Semi-structured interviews were conducted with clinicians (n = 10) and families (parents/young people, n = 20) who participated in a randomised controlled trial. Additionally, the same clinicians (n = 10) and families (n = 76) completed a survey assessing their experience of the QbTest. The study took place in child and adolescent mental health and community paediatric clinics across the UK. Interview transcripts were thematically analysed. RESULTS: Interviewed clinicians and families valued the QbTest for providing an objective, valid assessment of symptoms. The QbTest was noted to facilitate communication between clinicians, families and schools. However, whereas clinicians were more unanimous on the usefulness of the QbTest, survey findings showed that, although the majority of families found the test useful, less than half felt the QbTest helped them understand the clinician's decision making around diagnosis and medication. The QbTest was seen as a potentially valuable tool to use early in the assessment process to streamline the care pathway. Although clinicians were conscious of the additional costs, these could be offset by reductions in time to diagnosis and the delivery of the test by a Healthcare Assistant. CONCLUSIONS: The findings indicate the QbTest is an acceptable and feasible tool to implement in routine clinical settings. Clinicians should be mindful to discuss the QbTest results with families to enable their understanding and engagement with the process. Further findings from definitive trials are required to understand the cost/benefit; however, the findings from this study support the feasibility and acceptability of integrating QbTest in the ADHD care pathway. TRIAL REGISTRATION: The findings form the implementation component of the Assessing QbTest Utility in ADHD (AQUA) Trial which is registered with the ISRCTN registry ( ISRCTN11727351 , retrospectively registered 04 July 2016) and clinicaltrials.gov ( NCT02209116 , registered 04 August 2014).