Gordon PA, Rosenthal E, Khamashta MA, Hughes GR Absence of conduction defects in the electrocardiograms [correction of echocardiograms] of mothers with children with congenital complete heart block. J Rheumatol. 2001 Feb;28(2):366-9. Erratum in: J Rheumatol 2001 May;28(5):1200.
Lazzerini PE, Capecchi PL, Laghi-Pasini F Anti-Ro/SSA antibodies and cardiac arrhythmias in the adult: facts and hypotheses. Scand J Immunol. 2010 Sep;72(3):213-22. doi: 10.1111/j.1365-3083.2010.02428.x. Review.
Logar D, Kveder T, Rozman B, Dobovisek J Possible association between anti-Ro antibodies and myocarditis or cardiac conduction defects in adults with systemic lupus erythematosus. Ann Rheum Dis. 1990 Aug;49(8):627-9.
O'Neill TW, Mahmoud A, Tooke A, Thomas RD, Maddison PJ Is there a relationship between subclinical myocardial abnormalities, conduction defects and Ro/La antibodies in adults with systemic lupus erythematosus? Clin Exp Rheumatol. 1993 Jul-Aug;11(4):409-12.
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.
