Anneliese Synnot|Rebecca Ryan|Megan Prictor|Deirdre Fetherstonhaugh|Barbara Parker
Audio-visual presentation of information for informed consent for participation in clinical trials
La Trobe University|La Trobe University|La Trobe University|La Trobe University|La Trobe University
informed consent critical component clinical research different methods presenting information potential participants clinical trials may improve informed consent process audiovisual interventions presented example internet dvd one method updated 2008 review effects interventions informed consent trial participationto assess effects audiovisual information interventions regarding informed consent compared standard information placebo audiovisual interventions regarding informed consent potential clinical trial participants terms understanding satisfaction willingness participate anxiety psychological distresswe searched cochrane central register controlled trials central cochrane library issue 6 2012 medline ovidsp 1946 13 june 2012 embase ovidsp 1947 12 june 2012 psycinfo ovidsp 1806 june week 1 2012 cinahl ebscohost 1981 27 june 2012 current contents ovidsp 1993 week 27 2012 week 26 eric proquest searched 27 june 2012 also searched reference lists included studies relevant review articles contacted study authors experts language restrictionswe included randomised quasirandomised controlled trials comparing audiovisual information alone conjunction standard forms information provision written verbal information standard forms information provision placebo audiovisual information informed consent process clinical trials trials involved individuals guardians asked consider participating real hypothetical clinical study earlier version review included studies evaluating informed consent interventions real studiestwo authors independently assessed studies inclusion extracted data synthesised findings using metaanalysis possible narrative synthesis results assessed risk bias individual studies considered impact quality overall evidence strength resultswe included 16 studies involving data 1884 participants nine studies included participants considering real clinical trials eight included participants considering hypothetical clinical trials one including studies conducted highincome countriesthere still much uncertainty effect audiovisual informed consent interventions range patient outcomes however considered across comparisons found low low quality evidence interventions may slightly improve knowledge understanding parent trial may make little difference rate participation willingness participate audiovisual presentation informed consent may improve participant satisfaction consent information provided however effect satisfaction aspects process clear insufficient evidence draw conclusions anxiety arising audiovisual informed consent found conflicting low quality evidence whether audiovisual interventions took less time administer study measured researcher satisfaction informed consent process ease usethe evidence real clinical trials rated low quality outcomes hypothetical studies low note however large part due poor study reporting hypothetical nature studies low participant numbers rather inconsistent results studies confirmed poor trial quality believe studies funded organisations vested interest resultsthe value audiovisual interventions tool helping enhance informed consent process people considering participating clinical trials remains largely unclear although trends emerging regard improvements knowledge satisfaction many relevant outcomes evaluated randomised trials triallists continue explore innovative methods providing information potential trial participants informed consent process mindful range outcomes intervention designed achieve balancing resource implications intervention development delivery purported benefits interventionmore trials adhering consort standards conducted settings populations underserved review ie low middleincome countries people low literacy would strengthen results review broaden applicability assessing process measures time taken administer intervention researcher satisfaction would inform implementation audiovisual consent materials