Abstract：
:Randomized controlled trials (RCTs) have eligibility criteria for the inclusion of participants. Ideally, the RCT sample would be representative for the patient population that will use the drug under investigation. However, external validity may be at stake when applying too many or too restrictive eligibility criteria. The current two-part study examined (1) the currently applied eligibility criteria in Phase II and III RCTs examining sleep medication; (2) how these criteria match with the insomnia population as a whole; and (3) how inclusion rates can be changed by an adaptation of these criteria. In the first study, insomnia RCTs were screened at www.clinicaltrials.gov, and relevant eligibility criteria were identified. The second study comprised a survey among self-reported insomnia patients. It was determined to what extent RCT eligibility criteria match the characteristics of this patient population. Of the n = 519 patients that completed the survey only n = 2 (0.4%) met all eligibility criteria of current RCTs. RCT enrolment criteria are not representative for the insomnia patient population as a whole. Being less rigorous in applying upper or lower criteria limits results in a significant increase in the number of eligible patients, and increases the representativeness of RCTs for the insomnia patient population as a whole. The current analysis demonstrates that is important to thoroughly reconsider the use eligibility criteria and their inclusion ranges, and to have a theoretical basis for using them.
journal_name
J Clin Medjournal_title
Journal of clinical medicineauthors
Huls H,Abdulahad S,Mackus M,van de Loo AJAE,Roehrs T,Roth T,Verster JCdoi
10.3390/jcm7080206subject
Has Abstractpub_date
2018-08-08 00:00:00issue
8issn
2077-0383pii
jcm7080206journal_volume
7pub_type
杂志文章abstract：:C-reactive protein (CRP) and myxovirus resistance protein A (MxA) are associated with bacterial and viral infections, respectively. We conducted a prospective, multicenter, cross-sectional study of adults and children with febrile upper respiratory tract infections (URIs) to evaluate the diagnostic accuracy of a rapid...
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abstract：:The nociceptive withdrawal reflex (NWR) is used to probe spinal cord excitability in chronic pain states. Here, we used an automated and unbiased procedure for determining the NWR threshold and compared the reflex thresholds and corresponding pain ratings in a well-characterized cohort of fibromyalgia (n = 29) and mat...
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更新日期：2020-06-25 00:00:00
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更新日期：2017-02-13 00:00:00
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pub_type： 社论
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更新日期：2020-07-13 00:00:00
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更新日期：2019-12-18 00:00:00
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pub_type： 杂志文章
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journal_title：Journal of clinical medicine
pub_type： 杂志文章,评审
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更新日期：2018-08-29 00:00:00
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pub_type： 杂志文章
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更新日期：2019-06-05 00:00:00
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journal_title：Journal of clinical medicine
pub_type： 杂志文章,评审
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更新日期：2014-09-05 00:00:00
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journal_title：Journal of clinical medicine
pub_type： 杂志文章
doi：10.3390/jcm10030392
更新日期：2021-01-20 00:00:00
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journal_title：Journal of clinical medicine
pub_type： 杂志文章
doi：10.3390/jcm8111813
更新日期：2019-11-01 00:00:00
abstract：:The authors wish to make the following corrections to this paper [...]. ...
journal_title：Journal of clinical medicine
pub_type： 已发布勘误
doi：10.3390/jcm9020569
更新日期：2020-02-19 00:00:00
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journal_title：Journal of clinical medicine
pub_type： 杂志文章,评审
doi：10.3390/jcm8050716
更新日期：2019-05-20 00:00:00
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journal_title：Journal of clinical medicine
pub_type： 杂志文章
doi：10.3390/jcm10010085
更新日期：2020-12-29 00:00:00
abstract：:To date, studies have highlighted cross-sectional and unidirectional prospective relationships between problem gambling and mental health symptoms or substance use. The current study aims to: (1) examine the reciprocal relationships between problem gambling and mental health symptoms (depression, generalized anxiety)/...
journal_title：Journal of clinical medicine
pub_type： 杂志文章
doi：10.3390/jcm8111888
更新日期：2019-11-06 00:00:00
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journal_title：Journal of clinical medicine
pub_type： 杂志文章,评审
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更新日期：2019-11-08 00:00:00
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pub_type： 杂志文章
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更新日期：2020-04-24 00:00:00
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pub_type： 杂志文章
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更新日期：2019-05-08 00:00:00
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pub_type： 杂志文章
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更新日期：2019-10-04 00:00:00
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pub_type： 杂志文章,评审
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pub_type： 杂志文章,评审
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更新日期：2020-06-26 00:00:00
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更新日期：2018-05-28 00:00:00
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pub_type： 杂志文章,评审
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更新日期：2017-11-03 00:00:00
abstract：:Diabetes in pregnancy, both preexisting type 1 or type 2 and gestational diabetes, is a highly prevalent condition, which has a great impact on maternal and fetal health, with short and long-term implications. Gestational Diabetes Mellitus (GDM) is a condition triggered by metabolic adaptation, which occurs during the...
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更新日期：2018-01-25 00:00:00
abstract：:Healthcare resource utilization peaks throughout the first year following acute myocardial infarction (AMI). Data linking the former and outcomes are sparse. We evaluated the associations between subsequent length of in-hospital stay (SLOS) and primary ambulatory visits (PAV) within the first year after AMI and long-t...
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更新日期：2020-08-05 00:00:00
