ArticleJournal of clinical medicine2018
Inclusion and Exclusion Criteria of Clinical Trials for Insomnia.
Article in Journal of clinical medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Clinical Trial Generalizability Assessment in the Big Data Era: A Review.Clinical and translational science · 2020Pooled it
- Association of Protocol Design-Related Factors With Enrollment Duration in Clinical Trials.Clinical and translational science · 2026Article
- Insomnia and its treatments-trend analysis and publication profile of randomized clinical trials.Npj biological timing and sleep · 2024Article
- Sex and age differences in self-reported immune fitness.Brain, behavior, & immunity - health · 2024Article
- Evaluating the Impact of Exclusion Criteria on the Generalizability of Hidradenitis Suppurativa Treatment Research.JID innovations : skin science from molecules to population health · 2023Article
- The Assessment of Immune Fitness.Journal of clinical medicine · 2022Review
- Recruiting "clean" chronic insomnia participants: the unicorn of sleep research.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2022Article
- Pandemic Preparedness: Maintaining Adequate Immune Fitness by Attaining a Normal, Healthy Body Weight.Journal of clinical medicine · 2022Article
- Immune Fitness and the Psychosocial and Health Consequences of the COVID-19 Pandemic Lockdown in The Netherlands: Methodology and Design of the CLOFIT Study.European journal of investigation in health, psychology and education · 2021Article
- Brain Functional Mechanisms Determining the Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Primary Insomnia.Frontiers in neuroscience · 2021Article
- "Religious Belief": An Undervalued Ethical Inclusion Criterion for Clinical Trials on Bone Grafting Procedures.Journal of religion and health · 2020Review
- Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review.Contemporary clinical trials · 2020Article
- Article
- Advantages and Limitations of Naturalistic Study Designs and their Implementation in Alcohol Hangover Research.Journal of clinical medicine · 2019Article
- From Clinical Trial Efficacy to Real-Life Effectiveness: Why Conventional Metrics do not Work.Drugs - real world outcomes · 2019Article
- Insights for Oncology Trials Garnered From the Rapid Development of an mRNA COVID-19 Vaccine.Cancer journal (Sudbury, Mass.)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
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
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.