Rural-Urban Differences in the Impact of a Medicare Opioid Safety Policy on Beneficiaries with Disabilities.
Authors: Kwak J, Burnett A, Shuey B, Zhang F, Wharam JF, Wen H
Journal: American journal of preventive medicine
mental health
psychology
open access
Abstract
Randomized controlled trials represent the gold standard for generating evidence on
the efficacy and safety of interventions, thereby guiding their implementation in
clinical practice and public health programs.
However, relatively few trials are conducted in infants, as they are
facing unique challenges, particularly with respect to recruiting a representative
study sample within a short postnatal period.
Additional challenges include stringent ethical requirements and the
need to carefully balance the protection of the child's health with the
advancement of scientific knowledge. To support clinical research in infants, it is crucial to understand the factors
influencing participation among eligible families. Previous studies have reported
that non-participation is mainly due to modifiable factors, with parental refusal to
participate being most common.
Parents
must assess potential risks and make participation decisions during a vulnerable
period shortly after birth. Reported barriers to the enrollment of infants in
clinical trials include concerns about blood sampling
and research in general.
However, the reasons
for declining participation in primary prevention trials, involving infants at an
increased risk of disease but not yet affected, remain poorly understood. Recent advances in genetic screening have made it possible to identify newborns at
increased risk for type 1 diabetes (T1D), one of the most common chronic childhood
diseases, with a rising global incidence.
This progress has enabled the initiation of primary prevention trials
targeting at-risk infants.
While some data exist on enrollment
experiences from observational studies involving children at increased risk for
T1D,
no studies have examined
factors influencing their participation in primary prevention trials.
the efficacy and safety of interventions, thereby guiding their implementation in
clinical practice and public health programs.
However, relatively few trials are conducted in infants, as they are
facing unique challenges, particularly with respect to recruiting a representative
study sample within a short postnatal period.
Additional challenges include stringent ethical requirements and the
need to carefully balance the protection of the child's health with the
advancement of scientific knowledge. To support clinical research in infants, it is crucial to understand the factors
influencing participation among eligible families. Previous studies have reported
that non-participation is mainly due to modifiable factors, with parental refusal to
participate being most common.
Parents
must assess potential risks and make participation decisions during a vulnerable
period shortly after birth. Reported barriers to the enrollment of infants in
clinical trials include concerns about blood sampling
and research in general.
However, the reasons
for declining participation in primary prevention trials, involving infants at an
increased risk of disease but not yet affected, remain poorly understood. Recent advances in genetic screening have made it possible to identify newborns at
increased risk for type 1 diabetes (T1D), one of the most common chronic childhood
diseases, with a rising global incidence.
This progress has enabled the initiation of primary prevention trials
targeting at-risk infants.
While some data exist on enrollment
experiences from observational studies involving children at increased risk for
T1D,
no studies have examined
factors influencing their participation in primary prevention trials.