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1.
Value Health ; 27(1): 79-94, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37879401

RESUMO

While the use of electronic methods to collect patient-reported outcome data in clinical trials continues to increase, it remains the case that many patient-reported outcome measures (PROMs) have originally been developed and validated on paper. Careful consideration during the move from paper PROMs to electronic format is required to preserve the integrity of the measure and ensure a "faithful migration." Relevant literature has long called out the importance of following migration best practices during this process; nevertheless, such best practices are distributed across multiple documents. This article consolidates and builds upon existing electronic PROM implementation best practice recommendations to provide a comprehensive, up-to-date, single point of reference. It reflects the current consensus based on the significant advances in technology capabilities and knowledge gleaned from the growing evidence base on electronic migration and implementation, to balance the need for maintaining the integrity of the measure while optimizing respondent usability. It also specifies whether the practice is rooted in evidence or expert consensus, to enable those using these best practices to make informed and considered decisions when conducting migration.


Assuntos
Medidas de Resultados Relatados pelo Paciente , Humanos , Consenso
2.
Fortschr Neurol Psychiatr ; 89(12): 607-616, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33657626

RESUMO

Increasing evidence shows that unintentional mind wandering is linked to Attention Deficit Hyperactivity Disorder (ADHD) and that its frequency contributes to symptom severity and functional impairment in ADHD. However, empirical data on mind wandering in adult ADHD are still scarce, and a validated scale to assess mind wandering in German adult ADHD patients is lacking. The primary aim of this study is to assess the psychometric properties of the German version of the recently published Mind Excessively Wandering Scale (MEWS-G) in terms of factorial structure and factor stability, internal consistency and construct validity. Analyses were performed in 128 adults with ADHD, clinical and healthy controls. As described for the original English 15-item version of the scale, we found lowest item-total-correlations for items 6, 10 and 14 with item-total correlation of all: 0.54/ADHD: 0.32 (item 6), all: 0.55/ADHD: 0.39 (item 10) and all: 0.11/ADHD: -0.04 (item 14). Item-total correlations for the remaining items were 0.65-0.86 and Cronbach Alpha was 0.96 indicating good internal consistency of the 12-item version of scale, on which we based all further analyses. Principal component analysis indicated a one- and two- factorial scale structure respectively explaining 71.7 % and 78.7 % of variance. Both factors showed good stability with lower stability of the factor-2 solution if sample size was reduced. The two-factorial solution also had many cross-loadings and a strong correlation of both factors in confirmatory factorial analysis (rf1f2 = 0.87). It probably describes related and interdependent, but not distinct facets of mind wandering, which strongly argues for the one factorial structure of the scale. Mean MEWS-G score in ADHD was 23.77 ± 7.85 compared to 7.64 ± 7.27 in controls (p < .0001). According to ROC, the optimal cut-off point to discriminate ADHD and controls is at MEWS-G score = 13. On the symptom level, MEWS-G score was correlated with ADHD, depressive and total psychiatric symptom scores, on the personality level with neuroticsm and negatively with conscientiousness and on the functional level with social interaction difficulties and impaired self-efficacy. In summary, our study shows that MEWS-G is a reliable, valid instrument to assess spontaneous mind wandering in adult ADHD and to discriminate between ADHD and controls.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade , Adulto , Transtorno do Deficit de Atenção com Hiperatividade/diagnóstico , Humanos , Personalidade , Psicometria , Reprodutibilidade dos Testes
3.
Eur Child Adolesc Psychiatry ; 28(4): 481-489, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30097723

RESUMO

In youth, ADHD is more commonly diagnosed in males than females, but higher male-to-female ratios are found in clinical versus population-based samples, suggesting a sex bias in the process of receiving a clinical diagnosis of ADHD. This study investigated sex differences in the severity and presentation of ADHD symptoms, conduct problems, and learning problems in males and females with and without clinically diagnosed ADHD. We then investigated whether the predictive associations of these symptom domains on being diagnosed and treated for ADHD differed in males and females. Parents of 19,804 twins (50.64% male) from the Swedish population completed dimensional assessments of ADHD symptoms and co-occurring traits (conduct and learning problems) when children were aged 9 years. Children from this population sample were linked to Patient Register data on clinical ADHD diagnosis and medication prescriptions. At the population level, males had higher scores for all symptom domains (inattention, hyperactivity/impulsivity, conduct, and learning problems) compared to females, but similar severity was seen in clinically diagnosed males and females. Symptom severity for all domains increased the likelihood of receiving an ADHD diagnosis in both males and females. Prediction analyses revealed significant sex-by-symptom interactions on diagnostic and treatment status for hyperactivity/impulsivity and conduct problems. In females, these behaviours were stronger predictors of clinical diagnosis (hyperactivity/impulsivity: OR 1.08, 95% CI 1.01, 1.15; conduct: OR 1.43, 95% CI 1.09, 1.87), and prescription of pharmacological treatment (hyperactivity/impulsivity: OR 1.24, 95% CI 1.02, 1.50; conduct: OR 2.20, 95% CI 1.05, 4.63). Females with ADHD may be more easily missed in the ADHD diagnostic process and less likely to be prescribed medication unless they have prominent externalising problems.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/diagnóstico , Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Caracteres Sexuais , Gêmeos , Adolescente , Transtorno do Deficit de Atenção com Hiperatividade/epidemiologia , Transtorno do Deficit de Atenção com Hiperatividade/psicologia , Estimulantes do Sistema Nervoso Central/farmacologia , Estimulantes do Sistema Nervoso Central/uso terapêutico , Criança , Estudos de Coortes , Feminino , Humanos , Comportamento Impulsivo/efeitos dos fármacos , Comportamento Impulsivo/fisiologia , Estudos Longitudinais , Masculino , Pais/psicologia , Valor Preditivo dos Testes , Estudos Prospectivos , Suécia/epidemiologia , Resultado do Tratamento , Gêmeos/psicologia
4.
J Neurosci ; 33(43): 17023-8, 2013 Oct 23.
Artigo em Inglês | MEDLINE | ID: mdl-24155306

RESUMO

Evidence suggests that emotional memory plays a role in the pathophysiology of depression/anxiety disorders. Noradrenaline crucially modulates emotional memory. Genetic variants involved in noradrenergic signaling contribute to individual differences in emotional memory and vulnerability to psychopathology. A functional deletion polymorphism in the α-2B adrenoceptor gene (ADRA2B) has been linked to emotional memory and post-traumatic stress disorder. The noradrenaline reuptake inhibitor reboxetine attenuates enhanced memory for negative stimuli in healthy and depressed individuals. We examined whether the effect of reboxetine on emotional memory in healthy individuals would be moderated by ADRA2B genotype. ADRA2B deletion carriers demonstrated enhanced emotional memory for negative stimuli compared with deletion noncarriers, consistent with prior studies. Reboxetine attenuated enhanced memory for negative stimuli in deletion noncarriers but had no significant effect in deletion carriers. This is the first demonstration of genetic variation influencing antidepressant drug effects on emotional processing in healthy humans.


Assuntos
Inibidores da Captação Adrenérgica/farmacologia , Genótipo , Memória/efeitos dos fármacos , Morfolinas/farmacologia , Receptores Adrenérgicos alfa 2/genética , Adolescente , Adulto , Nível de Alerta/efeitos dos fármacos , Nível de Alerta/genética , Estudos de Casos e Controles , Emoções , Deleção de Genes , Estudos de Associação Genética , Voluntários Saudáveis , Homozigoto , Humanos , Masculino , Polimorfismo Genético , Reboxetina
5.
J Psychiatry Neurosci ; 39(3): E24-31, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24467942

RESUMO

BACKGROUND: Catechol-O-methyltransferase (COMT) metabolizes catecholamines in the prefrontal cortex (PFC). A common polymorphism in the COMT gene (COMT val158met) has pleiotropic effects on cognitive and emotional processing. The met allele has been associated with enhanced cognitive processing but impaired emotional processing relative to the val allele. METHODS: We genotyped healthy, white men in relation to the COMT val158met polymorphism. They were given a single 4 mg dose of the selective noradrenaline reuptake inhibitor (NRI) reboxetine or placebo in a randomized, double-blind between-subjects model and then completed an emotional memory task 2 hours later. RESULTS: We included 75 men in the study; 41 received reboxetine and 34 received placebo. In the placebo group, met/met carriers did not demonstrate the usual memory advantage for emotional stimuli that was observed in val carriers. Reboxetine restored this emotional enhancement of memory in met/met carriers, but had no significant effect in val carriers. LIMITATIONS: We studied only men, thus limiting the generalizability of our findings. We also relied on self-reported responses to screening questions to establish healthy volunteer status, and in spite of the double-blind design, participants were significantly better than chance at identifying their intervention allocation. CONCLUSION: Emotional memory is impaired in healthy met homozygotes and selectively improved in this group by reboxetine. This has potential translational implications for the use of reboxetine, which is currently licensed as an antidepressant in several countries, and edivoxetine, a new selective NRI currently in development.


Assuntos
Inibidores da Captação Adrenérgica/farmacologia , Catecol O-Metiltransferase/genética , Emoções/efeitos dos fármacos , Memória/efeitos dos fármacos , Morfolinas/farmacologia , Inibidores da Captação Adrenérgica/efeitos adversos , Método Duplo-Cego , Genótipo , Técnicas de Genotipagem , Humanos , Masculino , Morfolinas/efeitos adversos , Testes Neuropsicológicos , Polimorfismo Genético , Reboxetina , Adulto Jovem
6.
Front Psychol ; 14: 1181294, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37496793

RESUMO

Introduction: Over the last decade, excessive spontaneous mind wandering (MW) has been consistently associated with emotional disorders. The main aims of the present study were (1) to re-examine the factor structure of the Mind Excessively Wandering Scale (MEWS); (2) to validate the Spanish version of the MEWS; and (3) to conduct a cross-cultural validation of the MEWS in Spanish and UK samples. Methods: A forward/backward translation to Spanish was conducted. Data of 391 Spanish and 713 British non-clinical individuals were analysed. Results: A revised 10-item version of the MEWS (MEWS-v2.0) demonstrated to be a valid instrument to assess MW. A 2-correlated factor structure properly captured the MEWS-v2.0 variance, accounting for two specific but interrelated dimensions (Uncontrolled thoughts and Mental Overactivity). Discussion: The Spanish MEWS-v2.0 showed adequate internal consistency and construct validity, as well as appropriate convergent/divergent validity. Cross-cultural analyses showed that MEWS-v2.0 captured the same construct in both UK and Spanish samples. In conclusion, both Spanish and English MEWS-v2.0 demonstrated to be reliable measures to capture spontaneous MW phenomenon in non-clinical adult populations.

7.
Ther Innov Regul Sci ; 56(4): 531-535, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35534774

RESUMO

Bring-your-own-device (BYOD) methods for collecting patient-reported outcome (PRO) data in clinical trials can decrease patient burden and improve data quality. However, adoption of BYOD in clinical trials is limited by the absence of publicly available case studies where BYOD PRO data supported regulatory medical product approvals. Anecdotally, we are aware of multiple examples where efficacy and safety label claims were based on BYOD PRO data; however-except for one-these examples have not been made public. The absence of these case studies can lead sponsors to be hesitant to use BYOD for capturing primary and secondary PRO-based endpoints in their trials. This commentary outlines the context of the issue faced and concludes with a call for sponsor transparency with regard to BYOD use through publicizing where approved labeling claims were based on BYOD data. We suggest how this data could be systematically captured going forward. Sharing this information will benefit the clinical trials enterprise by increasing confidence in the utilization of BYOD and provide opportunities to enhance patient-centricity.


Assuntos
Medidas de Resultados Relatados pelo Paciente , Rotulagem de Produtos , Humanos
8.
J Child Adolesc Psychopharmacol ; 32(4): 233-241, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35501967

RESUMO

Objective: Anxiety disorders are among the most common co-occurring conditions in autism spectrum disorder (ASD). Despite their prevalence and impact, there are no randomized controlled trials (RCTs) aimed at evaluating the efficacy of selective serotonin reuptake inhibitors (SSRIs) for anxiolysis in this population, who may have a different biological basis for anxiety. Methods: Secondary analyses of the STAART double-blind, placebo-controlled RCT of citalopram in children with ASD examined whether citalopram reduced anxiety measured on the parent-reported Child and Adolescent Symptom Inventory-4 (CASI-4) as the primary outcome. An intention-to-treat analysis involving all 149 participants used multiple imputations for missing data and included baseline stratification factors of age group and site, among others. We prespecified as clinically significant a 33% reduction in anxiety in citalopram versus placebo, coinciding with 80% power. We tested whether communicative ability on the Vineland Communication score moderated treatment effect and explored whether initial anxiety was associated with greater adverse events, which could impact on dose titration and achieving optimal dose. Results: Both groups showed substantial reduction in anxiety. Citalopram was associated with a nonsignificant 16.5% greater reduction (observed coefficient = -0.181, bootstrap standard error = 0.126, p = 0.151, confidence interval = -0.428 to 0.066). Anxiety reports were significantly lower in children with reduced communicative ability, but communicative ability did not moderate the treatment effect (interaction p = 0.294). Initial anxiety levels were not associated with increased adverse effects (interaction ps 0.162-0.954). Conclusion: Citalopram did not statistically significantly improve anxiety in children with ASD. Clinicians should be cautious in their use of SSRIs for this indication. There remains a need for well-powered clinical trials testing the efficacy of SSRIs among autistic children with anxiety disorders.


Assuntos
Transtorno do Espectro Autista , Citalopram , Adolescente , Ansiedade/tratamento farmacológico , Transtornos de Ansiedade/tratamento farmacológico , Transtorno do Espectro Autista/complicações , Transtorno do Espectro Autista/tratamento farmacológico , Criança , Citalopram/uso terapêutico , Humanos , Inibidores Seletivos de Recaptação de Serotonina/uso terapêutico
9.
J Comp Eff Res ; 9(17): 1195-1204, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33274651

RESUMO

Aim: To understand the impact of anticancer treatment on oncology patients' ability to use electronic solutions for completing patient-reported outcomes (ePRO). Materials & methods: Semi-structured interviews were conducted with seven individuals who had experienced a cancer diagnosis and treatment. Results: Participants reported that the following would impact the ability to interact with an ePRO solution: peripheral neuropathy of the hands (4/7), fatigue and/or concentration and memory issues (6/7), where they are in a treatment cycle (5/7). Approaches to improve usability included: larger, well-spaced buttons to deal with finger numbness, the ability to pause a survey and complete at a later point and presenting the recall period with every question to reduce reliance on memory. Conclusion: Symptoms associated with cancers and anticancer treatments can impact the use of technologies. The recommendations for optimizing the electronic implementation of patient-reported outcome instruments in this population provides the potential to improve data quality in oncology trials and places patient needs at the forefront to ensure 'fit-for-purpose' solutions.


Assuntos
Antineoplásicos/uso terapêutico , Ensaios Clínicos como Assunto , Registros Eletrônicos de Saúde , Neoplasias/tratamento farmacológico , Medidas de Resultados Relatados pelo Paciente , Humanos , Avaliação de Resultados em Cuidados de Saúde , Pesquisa Qualitativa , Inquéritos e Questionários
10.
Eur Neuropsychopharmacol ; 38: 98-109, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32703662

RESUMO

Attention-deficit/hyperactivity Disorder (ADHD) and borderline personality disorder (BPD) have overlapping symptoms. We proposed that excessive spontaneous mind wandering (MW-S) might reflect a component of psychopathology that distinguishes ADHD from BPD. Using a questionnaire measure of MW-S and an experience sampling method, we investigated MW-S in daily life, in 28 ADHD, 19 BPD, 22 comorbid ADHD+BPD, and 29 control females. The clinical groups reported heightened frequency and intensity of MW-S compared to controls, but no differences from each other. When controlling for depression and anxiety, significant differences only persisted between controls and ADHD, who also showed elevated intensity of MW-S compared to BPD and comorbid ADHD+BPD. We found no MW-S instability differences amongst clinical cases as well as cases versus controls. Negative content of MW-S was higher in BPD and comorbid ADHD+BPD compared to controls, with no differences between ADHD and controls. When controlling for depression/anxiety, the differences between BPD and comorbid ADHD+BPD and controls dissipated. MW-S is a trans-diagnostic process present in both ADHD and BPD. Yet, the underlying mechanisms of this experience may be driven by anxiety/depression in BPD but reflect a core process in ADHD.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/psicologia , Atenção/fisiologia , Transtorno da Personalidade Borderline/psicologia , Fantasia , Autorrelato , Adolescente , Adulto , Idoso , Transtorno do Deficit de Atenção com Hiperatividade/diagnóstico , Transtorno da Personalidade Borderline/diagnóstico , Feminino , Humanos , Pessoa de Meia-Idade , Adulto Jovem
11.
Psychiatry Res ; 272: 765-773, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30832197

RESUMO

We investigate if different factors influence whether girls versus boys meet diagnostic criteria for attention-deficit/hyperactivity disorder(ADHD) among children with high ADHD symptoms. Participants were 283 children aged 7-12 from a population-based study. Girls and boys meeting diagnostic criteria for ADHD, based on an objective investigator-based interview, were compared to children who did not meet criteria despite high symptoms on a rating-scale measure of ADHD. We assessed factors that could differentially relate to diagnosis across girls and boys including ADHD symptoms, co-occurring behavioural/emotional problems and impairment, and sex-effects in rater perceptions of ADHD symptoms. While overall similar factors distinguished girls and boys who met diagnostic criteria from high-symptom peers, effect sizes were larger in girls. Emotional problems were particularly salient to distinguishing diagnosed versus high-symptom girls but not boys. Parents rated boys meeting diagnostic criteria as more impaired than high-symptom boys but did not do so for girls, and under-rated diagnosed girls' hyperactive/impulsive symptoms compared to more objective interview assessment, with the opposite observed in boys. Results suggest girls' ADHD may need to be made more prominent by additional behavioural/emotional problems for them to meet full diagnostic criteria and that sex differences in parental perceptions of ADHD behaviours and impairment exist.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/diagnóstico , Transtorno do Deficit de Atenção com Hiperatividade/psicologia , Comportamento Impulsivo/fisiologia , Caracteres Sexuais , Adolescente , Criança , Comorbidade , Feminino , Humanos , Masculino , Pais/psicologia , Grupo Associado , Fatores Sexuais
12.
Sci Rep ; 9(1): 3071, 2019 02 28.
Artigo em Inglês | MEDLINE | ID: mdl-30816143

RESUMO

Recent studies highlight the role of excessive mind wandering in attention-deficit/hyperactivity disorder (ADHD) and its association with impairment. We believe assessing mind wandering could be especially relevant to individuals, including many females, who present with less externalising manifestations of ADHD. Using a new measure based on ADHD patient reports, the Mind Excessively Wandering Scale (MEWS), we previously found adults with ADHD had elevated levels of mind wandering that contributed to impairment independently of core ADHD symptoms. Using data from an online general population survey, the current study assessed the factor-structure, reliability, validity and measurement invariance of the MEWS. We also investigated sex differences in mind wandering, as well as ADHD symptoms, impairment and wellbeing in those with and without ADHD. The MEWS had a unidimensional structure, was invariant across sex, age and ADHD status, and accounted for unique variance in impairment and wellbeing beyond core ADHD symptoms. Among those with ADHD, we found no evidence for sex differences in mind wandering and among those without ADHD males had higher scores. We also found similar levels of hyperactivity/impulsivity, emotional lability, and impairment in males and females with ADHD, but males reported greater inattention and lower wellbeing. Results suggest the MEWS is a reliable and valid instrument measuring the same construct across sex, age and ADHD status, which could aid diagnosis and monitoring of outcomes.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/psicologia , Atenção , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Transtorno do Deficit de Atenção com Hiperatividade/epidemiologia , Emoções , Feminino , Humanos , Comportamento Impulsivo , Masculino , Pessoa de Meia-Idade , Fatores Sexuais , Adulto Jovem
13.
J Atten Disord ; 23(6): 624-634, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27255536

RESUMO

OBJECTIVE: This study investigates excessive mind wandering (MW) in adult ADHD using a new scale: the Mind Excessively Wandering Scale (MEWS). METHOD: Data from two studies of adult ADHD was used in assessing the psychometric properties of the MEWS. Case-control differences in MW, the association with ADHD symptoms, and the contribution to functional impairment were investigated. RESULTS: The MEWS functioned well as a brief measure of excessive MW in adult ADHD, showing good internal consistency (α > .9), and high sensitivity (.9) and specificity (.9) for the ADHD diagnosis, comparable with that of existing ADHD symptom rating scales. Elevated levels of MW were found in adults with ADHD, which contributed to impairment independently of core ADHD symptom dimensions. CONCLUSION: Findings suggest excessive MW is a common co-occurring feature of adult ADHD that has specific implications for the functional impairments experienced. The MEWS has potential utility as a screening tool in clinical practice to assist diagnostic assessment.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/complicações , Transtorno do Deficit de Atenção com Hiperatividade/fisiopatologia , Atenção/fisiologia , Função Executiva/fisiologia , Memória de Curto Prazo , Atenção Plena , Adulto , Transtorno do Deficit de Atenção com Hiperatividade/psicologia , Estudos de Casos e Controles , Feminino , Humanos , Masculino , Comportamento Errante
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