Barr RG, Barr M, Fujiwara T, Conway J, Catherine N, Brant R Do educational materials change knowledge and behaviour about crying and shaken baby syndrome? A randomized controlled trial. CMAJ. 2009 Mar 31;180(7):727-33. doi: 10.1503/cmaj.081419. Epub 2009 Mar 2.
Barr RG The normal crying curve: what do we really know? Dev Med Child Neurol. 1990 Apr;32(4):356-62.
Duursma E, Augustyn M, Zuckerman B Reading aloud to children: the evidence. Arch Dis Child. 2008 Jul;93(7):554-7. doi: 10.1136/adc.2006.106336. Epub 2008 May 13. Review.
Evanoo G Infant crying: a clinical conundrum. J Pediatr Health Care. 2007 Sep-Oct;21(5):333-8. Review.
Keeton CP, Perry-Jenkins M, Sayer AG Sense of control predicts depressive and anxious symptoms across the transition to parenthood. J Fam Psychol. 2008 Apr;22(2):212-21. doi: 10.1037/0893-3200.22.2.212.
Lee C, Barr RG, Catherine N, Wicks A Age-related incidence of publicly reported shaken baby syndrome cases: is crying a trigger for shaking? J Dev Behav Pediatr. 2007 Aug;28(4):288-93.
Lewin L Shaken baby syndrome: facts, education, and advocacy. Nurs Womens Health. 2008 Jun;12(3):235-9. doi: 10.1111/j.1751-486X.2008.00328.x.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.