Béatrice Perrenoud|Venetia-Sofia Velonaki|Patrick Bodenmann|Anne?Sylvie Ramelet
The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol
University of Lausanne|University of Lausanne|University of Lausanne
review questionobjective aim systematic review establish best available evidence effectiveness health literacy interventions informed consent process health care users specific review question effectiveness health literacy interventions health care users informed consent health procedures processes background informed consent fundamental principal health care context nowadays includes patients capacity judge involved decision making concerning care ensures care received reflects goals preferences values1 importance obtaining valid consent medical procedure wellestablished us court case 19142 stated right adult capability making decisions concerning body surgical operation without patients consent could considered assault another us court case3 court stated doctors duty make reasonable disclosure patient nature probable consequences dangers proposed treatment patient application doctrine informed consent legal procedure may slightly differ country country state state may different forms even within country example uk consent written verbal nonverbalimplied written consent form actual consent merely serves evidence consent given elements voluntariness appropriate information capacity satisfied signed informed consent form make consent valid4 nowadays widely accepted prior application medical procedure benefits risks alternatives must explained patient competent patient voluntarily understandingly consented5 hence informed consent refers health professionals obligation information disclosure patient quality patients understanding decision making6 words refer single moment agreement whole complex process gaining information deciding consenting7 several factors may restrict informed consent including patients competence provision limited information ineffective communication patients professionals hospital environment privacy problems8 according world health organization people increasingly urged make choices family members regards health care use however time inadequate problematic health literacy skills reported approximately half adult population eight european countries9 health literacy linked literacy entails peoples knowledge motivation competences access understand appraise apply health information order make judgments take decisions everyday life concerning health care disease prevention health promotion maintain improve quality life life course10p3 many instruments measuring either health literacy general dimensions health literacy eg numeracy health literacy related specific issues eg nutrition diabetes health literacy specific populations eg adolescents1112 diversity existing instruments includes diversity terms scoring ranges makes comparison results different studies difficult1113 index thresholds ranges different levels health literacy tools set based either well established health literacy instruments used study14 experts assessments required health literacy scores15 adequate health literacy could considered capacity successfully completing tasks required function health care setting16 low inadequate health literacy found several adverse effects health health care use reduced ability take medications properly interpret labels health messages poorer overall health status higher risk mortality seniors increased emergency department hospital use decreased use preventive interventions17 health literacy informed consent studies examining relationship health literacy informed consent conclude patients low health literacy less likely participate decision making concerning health care1819 according recent literature review20 health care users literacy together factors found important determinants patients capacity provide fully informed consent according review 21 86 patients able recall potential risks complications medical procedure percentage may even lower included studies referred selfreported recall may flawed measure21 according literature much written material related informed consent difficult health care users understand2223 addition study mccarthy et al24 observed consultations physicians spoke used significantly complex language patients may result inappropriate communication patients mainly limited literacy situations described may raise number critical legal ethical problems23 health professionals shape conditions interactions patient responsible adapting appropriate interventions communication approaches25 take account patients health literacy26 interventions could major contribution improvement informed consent process interventions sheridan et al27 conducted systematic review interventions designed reduce effects limited health literacy general outcomes included studies comprehension behavioral intent outcomes could strongly related informed consent process without making distinction studies referring informed consent process conclude several health literacy interventions example adding video narrative could improve individuals comprehension schenker et al28 conducted systematic review interventions improve patient comprehension medical surgical procedures including articles published 2008 one conclusions studies particular attention needed interventions provided patients limited literacy literacy patients addressed assessed since many articles health literacy informed consent published according recent review best practices new models health literacy informed consent29 includes papers published 2004 2014 half collected articles published since 2010 review limited literature within us territories focus evaluation recommended practices literature concludes different tactics simplifying written documents clarifying verbal exchanges use multimedia formats computerized exchanges might ameliorate constraints health literate communications required informed consent studies evaluated effectiveness health literacy interventions aim improve informed consent process3031323334 improvement informed consent process may refer patients comprehension also example recall information provided intention ask clarifications satisfaction procedure interventions described tested literature focus improvement print material process eg communication appropriate information davis et al30 conducted randomized controlled trial compare two polio vaccine pamphlets written sixth grade level international standardized pamphlet easytoread pamphlet comprehension preference among parents although parents intervention group n304 achieved significantly higher comprehension control group n306 65 vs 60 p0005 authors concluded simplifying written material increases appeal comprehension adequate level without use instructional graphics similarly lorenzen et al31 found reader friendly informed consent document surgical procedures commonly read health care users compared original consent document however difference found terms participants capacity describe procedure words kang et al32 evaluated recall comprehension orthodontic informed consent among pairs children parents n90 applying three different informed consent procedures according study combination improving readability consent materials informed consent process audio visual cues led better recall patients better recall comprehension parents compared improved readability form usual informed consent form smith et al33 used randomized controlled trial compare decision aid booklet dvd specifically designed adults low literacy skills n357 standard information booklet n173 screening bowel cancer found proportion participants making informed choice 22 higher intervention group control group 34 vs 12 p0001 matsuyama et al34 demonstrated education video codesigned expert patient health literacy improved patients n32 awareness radiation therapy asked provide informed consent treatment mean number correct responses respondents increased 23 units 21question survey watching video p00001 95 ci 1330 authors concluded video intervention led significant improvement knowledge regardless participants health literacy level interventions improve informed consent process research subjects low literacy already included recent systematic review35 search jbi database systematic reviews implementation reports cochrane library dare trip database locate systematic review protocol systematic review identify health literacy interventions concerning informed consent health procedures reason aim systematic review identify appraise synthesize best available evidence interventions improve health care users informed consent process taking account health literacy summarize evidence effectiveness enhancing health care users informed consent health procedures processes results systematic review could useful health care professionals policy makers informed consent essential part everyday health care definitions terms informed consent informed consent individuals autonomous authorization medical intervention participation research5p78 review refer informed consent health care intervention health literacy health literacy degree individuals capacity obtain process understand basic health information services needed make appropriate health decisions36para7 review health literacy refers consideration least one five skills literacy proposed health literacy studies institute medicine report37 skills reading writing numeracy oral communication listening comprehension