Cunningham JA, Neighbors C, Wild C, Humphreys K Ultra-brief intervention for problem drinkers: results from a randomized controlled trial. PLoS One. 2012;7(10):e48003. doi: 10.1371/journal.pone.0048003. Epub 2012 Oct 24.
DiMatteo MR Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004 Mar;42(3):200-9.
Finnie RK, Felder TM, Linder SK, Mullen PD Beyond reading level: a systematic review of the suitability of cancer education print and Web-based materials. J Cancer Educ. 2010 Dec;25(4):497-505. doi: 10.1007/s13187-010-0075-0. Review.
Fox R Informed choice in screening programmes: do leaflets help? A critical literature review. J Public Health (Oxf). 2006 Dec;28(4):309-17. Epub 2006 Oct 23. Review.
Francis NA, Butler CC, Hood K, Simpson S, Wood F, Nuttall J Effect of using an interactive booklet about childhood respiratory tract infections in primary care consultations on reconsulting and antibiotic prescribing: a cluster randomised controlled trial. BMJ. 2009 Jul 29;339:b2885. doi: 10.1136/bmj.b2885.
Galaal K, Bryant A, Deane KH, Al-Khaduri M, Lopes AD Interventions for reducing anxiety in women undergoing colposcopy. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD006013. doi: 10.1002/14651858.CD006013.pub3. Review.
Gauchet A, Tarquinio C, Fischer G Psychosocial predictors of medication adherence among persons living with HIV. Int J Behav Med. 2007;14(3):141-50.
Heaney D, Wyke S, Wilson P, Elton R, Rutledge P Assessment of impact of information booklets on use of healthcare services: randomised controlled trial. BMJ. 2001 May 19;322(7296):1218-21.
Johnson A, Sandford J, Tyndall J Written and verbal information versus verbal information only for patients being discharged from acute hospital settings to home. Cochrane Database Syst Rev. 2003;(4):CD003716. Review.
Johnson A, Sandford J Written and verbal information versus verbal information only for patients being discharged from acute hospital settings to home: systematic review. Health Educ Res. 2005 Aug;20(4):423-9. Epub 2004 Nov 30. Review.
Morisky DE, Ang A, Krousel-Wood M, Ward HJ Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54.
Nicolson D, Knapp P, Raynor DK, Spoor P Written information about individual medicines for consumers. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD002104. doi: 10.1002/14651858.CD002104.pub3. Review.
Talen MR, Muller-Held CF, Eshleman KG, Stephens L Patients' communication with doctors: a randomized control study of a brief patient communication intervention. Fam Syst Health. 2011 Sep;29(3):171-83. doi: 10.1037/a0024399.
Turpin G, Downs M, Mason S Effectiveness of providing self-help information following acute traumatic injury: randomised controlled trial. Br J Psychiatry. 2005 Jul;187:76-82.
Wells FO Patient information--the present and the future. J R Soc Med. 1990 May;83(5):300-2.
Yardley L, Barker F, Muller I, Turner D, Kirby S, Mullee M, Morris A, Little P Clinical and cost effectiveness of booklet based vestibular rehabilitation for chronic dizziness in primary care: single blind, parallel group, pragmatic, randomised controlled trial. BMJ. 2012 Jun 6;344:e2237. doi: 10.1136/bmj.e2237.
Zapata LB, Steenland MW, Brahmi D, Marchbanks PA, Curtis KM Patient understanding of oral contraceptive pill instructions related to missed pills: a systematic review. Contraception. 2013 May;87(5):674-84. doi: 10.1016/j.contraception.2012.08.026. Epub 2012 Oct 4. Review.
Ziegler A, Hadlak A, Mehlbeer S, König IR Comprehension of the description of side effects in drug information leaflets: a survey of doctors, pharmacists and lawyers. Dtsch Arztebl Int. 2013 Oct;110(40):669-73. doi: 10.3238/arztebl.2013.0669. Epub 2013 Oct 4.
Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication and Adherence in Emergency Ward
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.