Armstrong AW, Alikhan A, Cheng LS, Schupp C, Kurlinkus C, Eisen DB Portable video media for presenting informed consent and wound care instructions for skin biopsies: a randomized controlled trial. Br J Dermatol. 2010 Nov;163(5):1014-9. doi: 10.1111/j.1365-2133.2010.10067.x.
Bowers N, Eisenberg E, Montbriand J, Jaskolka J, Roche-Nagle G Using a multimedia presentation to improve patient understanding and satisfaction with informed consent for minimally invasive vascular procedures. Surgeon. 2017 Feb;15(1):7-11. doi: 10.1016/j.surge.2015.09.001. Epub 2015 Oct 14.
Bulka CM, Shotwell MS, Gupta RK, Sandberg WS, Ehrenfeld JM Regional anesthesia, time to hospital discharge, and in-hospital mortality: a propensity score matched analysis. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):381-6. doi: 10.1097/AAP.0000000000000121. Erratum In: Reg Anesth Pain Med. 2015 May-Jun;40(3):297.
Celik EC, Ekinci M, Ciftci B, Golboyu BE, Kilinc OO Influence of visual information on consent for invasive procedures in intensive care unit. Niger J Clin Pract. 2018 May;21(5):609-613. doi: 10.4103/njcp.njcp_437_16.
Galos DK, Taormina DP, Crespo A, Ding DY, Sapienza A, Jain S, Tejwani NC Does Brachial Plexus Blockade Result in Improved Pain Scores After Distal Radius Fracture Fixation? A Randomized Trial. Clin Orthop Relat Res. 2016 May;474(5):1247-54. doi: 10.1007/s11999-016-4735-1. Epub 2016 Feb 11.
Groves ND, Humphreys HW, Williams AJ, Jones A Effect of informational internet web pages on patients' decision-making: randomised controlled trial regarding choice of spinal or general anaesthesia for orthopaedic surgery. Anaesthesia. 2010 Mar;65(3):277-82. doi: 10.1111/j.1365-2044.2009.06211.x.
Jlala HA, French JL, Foxall GL, Hardman JG, Bedforth NM Effect of preoperative multimedia information on perioperative anxiety in patients undergoing procedures under regional anaesthesia. Br J Anaesth. 2010 Mar;104(3):369-74. doi: 10.1093/bja/aeq002. Epub 2010 Feb 1.
Kickbusch IS Health literacy: addressing the health and education divide. Health Promot Int. 2001 Sep;16(3):289-97. doi: 10.1093/heapro/16.3.289.
Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
Mawhinney G, Thakar C, Williamson V, Rothenfluh DA, Reynolds J Oxford Video Informed Consent Tool (OxVIC): a pilot study of informed video consent in spinal surgery and preoperative patient satisfaction. BMJ Open. 2019 Jul 24;9(7):e027712. doi: 10.1136/bmjopen-2018-027712.
O'Donnell BD, Ryan H, O'Sullivan O, Iohom G Ultrasound-guided axillary brachial plexus block with 20 milliliters local anesthetic mixture versus general anesthesia for upper limb trauma surgery: an observer-blinded, prospective, randomized, controlled trial. Anesth Analg. 2009 Jul;109(1):279-83. doi: 10.1213/ane.0b013e3181a3e721.
Salzwedel C, Petersen C, Blanc I, Koch U, Goetz AE, Schuster M The effect of detailed, video-assisted anesthesia risk education on patient anxiety and the duration of the preanesthetic interview: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):202-9, table of contents. doi: 10.1213/01.ane.0000287665.96156.72.
Sury MR, Palmer JH, Cook TM, Pandit JJ The state of UK anaesthesia: a survey of National Health Service activity in 2013. Br J Anaesth. 2014 Oct;113(4):575-84. doi: 10.1093/bja/aeu292. Epub 2014 Aug 7.
Tipotsch-Maca SM, Varsits RM, Ginzel C, Vecsei-Marlovits PV Effect of a multimedia-assisted informed consent procedure on the information gain, satisfaction, and anxiety of cataract surgery patients. J Cataract Refract Surg. 2016 Jan;42(1):110-6. doi: 10.1016/j.jcrs.2015.08.019.
Williams BA, Bottegal MT, Kentor ML, Irrgang JJ, Williams JP Rebound pain scores as a function of femoral nerve block duration after anterior cruciate ligament reconstruction: retrospective analysis of a prospective, randomized clinical trial. Reg Anesth Pain Med. 2007 May-Jun;32(3):186-92. doi: 10.1016/j.rapm.2006.10.011.
Woodall NM, Cook TM National census of airway management techniques used for anaesthesia in the UK: first phase of the Fourth National Audit Project at the Royal College of Anaesthetists. Br J Anaesth. 2011 Feb;106(2):266-71. doi: 10.1093/bja/aeq339. Epub 2010 Dec 4.
Zarnegar R, Brown MR, Henley M, Tidman V, Pathmanathan A Patient perceptions and recall of consent for regional anaesthesia compared with consent for surgery. J R Soc Med. 2015 Nov;108(11):451-6. doi: 10.1177/0141076815604494. Epub 2015 Oct 2.
Zhang Y, Ruan X, Tang H, Yang W, Xian Z, Lu M Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial. J Ophthalmol. 2017;2017:9593631. doi: 10.1155/2017/9593631. Epub 2017 Jan 16.
CIA: Consent in Anaesthesia, Prospective Randomised-controlled Trial
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.