Depression in Children and Adolescents: The Pediatrician at the Front Lines

Dawson, Rachel

doi:10.3928/19382359-20180618-01

Cited by 9 publications

(10 citation statements)

References 7 publications

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“…It expressed concerns that the black-box warning could reduce appropriate prescribing. The American Academy of Child and Adolescent Psychiatry (AACAP) has stated that the black-box warning was inconsistent with research and clinical experience 54. However, representative pediatric and psychiatric bodies have not acknowledged the suicidal consequences of the black-box warning, nor have they challenged the definition of “children.”32 Furthermore, the committee decision leading to the FDA’s black-box warning was not unanimous,1 and there was disagreement between clinicians and the FDA’s interpretation of the related studies.…”

Section: Resultsmentioning

confidence: 99%

Rational Use of Medicine in Children—The Conflict of Interests Story. A Review

Rose¹,

Neubauer²,

Grant‐Kels³

2019

Rambam Maimonides Med J

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Background United States (US) and European Union (EU) legislation attempts to counterbalance the presumed discrimination in pediatric drug treatment and development. Methods We analyzed the history of drug development, US/EU pediatric laws, and pediatric studies required by US/EU regulatory authorities and reviewed relevant literature. Results The US and EU definitions of a child are defined administratively (rather than physiologically) as being aged <17 years and <18 years, respectively. However, children mature physiologically well before their seventeenth or eighteenth birthdays. The semantic blur for these differing definitions may indicate certain conflicts of interest. Conclusions Pediatric healthcare today is better than ever. Regulatory-related requirements for “pediatric” studies focus on labeling. Most of these studies lack medical usefulness and may even harm “pediatric” patients through administration of placebo and/or substandard treatment, despite the resultant publications, networking, patent extensions, and strengthened regulatory standing. Clinicians, parents, and ethics committees should be aware of these issues. New rules are needed to determine new pharmaceutical dose estimates in prepubescent patients, and when/how to clinically confirm them. Internet-based structures to divulge this information should be established between drug developers, clinicians, and regulatory authorities. A prerequisite for the rational use of pharmaceuticals in children would be to correct the flawed concept that children are discriminated against in drug treatment and development, and to abandon separate “pediatric” drug approval processes.

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Section: Resultsmentioning

confidence: 99%

Rational Use of Medicine in Children—The Conflict of Interests Story. A Review

Rose¹,

Neubauer²,

Grant‐Kels³

2019

Rambam Maimonides Med J

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“…The regulatory authorities' reaction was different worldwide, 30 but gradually in the clinical world the position emerged that treatment of young depressed patients is necessary and needs to be done with caution. [30][31][32][33] Regulatory authorities should not interfere in medical practice. If deadly unexpected risks of a drug are discovered, this needs to be communicated, and in some cases the drug should be withdrawn from the market, balancing risks and benefits.…”

Section: Introductionmentioning

confidence: 99%

The Meanings of “Pediatric Drug Development”

Rose¹,

Grant‐Kels

2019

Ther Innov Regul Sci

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Pediatric drug development (PDD) became an industry goal when the Food and Drug Administration (FDA) granted patent extensions. This was later expanded to obligations for pediatric studies and to the European Medicines Agency’s (EMA’s) strict pediatric investigation plans (PIPs). Industry now sponsors many often international studies in young patients that are difficult or impossible to recruit. PDD’s intellectual foundations characterize children as “therapeutic orphans,” allegedly discriminated in drug treatment and development. While toxicities occured in newborns, demanding separate efficacy and safety (E&S) studies in all age groups is wasteful and reflects hidden conflicts of interest. The American Academy of Pediatrics (AAP) successfully procured pediatric research funds; the FDA dislikes pediatric off-label use and envisions labels as instructions for physicians. Pediatricians have continuously improved child health care by careful use of available drugs. Instead of physiologically defining children vis-à-vis drug treatment, the FDA defines children as ≤16 years old, offering convincing pretense for the need for mostly senseless “pediatric” studies in young adults, adolescents, and children. Although these studies may help advance pediatric academic careers, they do not improve pediatric health care. The EMA defines children as <18 years old and demands even more senseless and potentially harmful “pediatric” studies. Young patients need pharmacokinetic/pharmacodynamic and dose finding, but not separate E&S, studies. Institutional review boards and ethics committees should suspend or reject questionable FDA/EMA-demanded “pediatric” studies. Industry and science need repositioning towards “PDD”; US/EU pediatric laws need revision. We hope this will not take decades.

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“…Hypothetical DIF can be generated based on the fact that women present higher scores on self-reported depression measures than men (24, 25) and there are also age-related differences in the manifestation of depressive symptoms (26). Consequently, some symptoms would reflect a more severe depressive state than other symptoms among college students.…”

Section: Introductionmentioning

confidence: 99%

Can Gender and Age Impact on Response Pattern of Depressive Symptoms Among College Students? A Differential Item Functioning Analysis

et al. 2019

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Background: Self-reported depressive complaints among college students might indicate different degrees of severity of depressive states. Through the framework of item response theory, we aim to describe the pattern of responses to items of the Beck Depression Inventory-II (BDI-II), in terms of endorsement probability and discrimination along the continuum of depression. Potential differential item functioning of the scale items of the BDI-II is investigated, by gender and age, to compare across sub-groups of students. Methods: The 21-item BDI-II was cross-sectionally administered to a representative sample of 12,677 Brazilian college students. Reliability was evaluated based on Cronbach's alpha coefficient. Severity ( b i ) and discrimination ( a ) parameters of each BDI-II items were calculated through the graded response model. The influence of gender and age were tested for differential item functioning (DIF) within the item response theory-based approach. Results: The BDI-II presented good reliability (α = 0.91). Women and younger students significantly presented a higher likelihood of depression (cut-off > 13) than men and older counterparts. In general, participants endorsed more easily cognitive-somatic items than affective items of the scale. “Guilty feelings,” “suicidal thoughts,” and “loss of interest in sex” were the items that most likely indicated depression severity ( b ≥ 3.60). However, all BDI-II items showed moderate-to-high discrimination ( a ≥ 1.32) for depressive state. While two items were flagged for DIF, “crying” and “loss of interest in sex,” respectively for gender and age, the global weight of these items on the total score was negligible. Conclusions: Although respondents' gender and age might present influence on response pattern of depressive symptoms, the measures of self-reported symptoms have not inflated severity scores. These findings provide further support to the validity of using BDI-II for assessing depression in academic contexts and highlight the value of considering gender- and age-related common symptoms of depression.

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Depression in Children and Adolescents: The Pediatrician at the Front Lines

Cited by 9 publications

References 7 publications

Rational Use of Medicine in Children—The Conflict of Interests Story. A Review

Rational Use of Medicine in Children—The Conflict of Interests Story. A Review

The Meanings of “Pediatric Drug Development”

Can Gender and Age Impact on Response Pattern of Depressive Symptoms Among College Students? A Differential Item Functioning Analysis

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