There is increasing recognition of the importance of addressing health literacy in patient decision aid (PtDA) development.
Purpose
An updated review as part of IPDAS 2.0 examined the extent to which PtDAs are designed to meet the needs of people with low health literacy/socially-disadvantaged populations.
Data Sources
Reference lists of Cochrane reviews of randomized controlled trials (RCTs) of PtDAs (2014, 2017, and upcoming 2021 versions).
Study Selection
RCTs that assessed the impact of PtDAs on low health literacy or other socially-disadvantaged groups (i.e., ≥50% participants from socially-disadvantaged groups and/or subgroup analysis in socially-disadvantaged group/s).
Data Extraction
Two researchers independently extracted data into a standardized form including PtDA development and evaluation details. We searched online repositories and emailed authors to access PtDAs to verify grade reading level, understandability, and actionability.
Data Synthesis
Twenty-five of 213 RCTs met the inclusion criteria, illustrating that only 12% of studies addressed the needs of low health literacy or other socially-disadvantaged groups. Grade reading level was calculated in 8 of 25 studies (33%), which is recommended in previous IPDAS guidelines. We accessed and independently assessed 11 PtDAs. None were written at sixth-grade level or below. Ten PtDAs met the recommended threshold for understandability, but only 5 met the recommended threshold for actionability. We also conducted a post hoc subgroup meta-analysis and found that knowledge improvements after receiving a PtDA were greater in studies that reported using strategies to reduce cognitive demand in PtDA development compared with studies that did not (χ2 = 14.11, P = 0.0002, I2 = 92.9%).
Limitations
We were unable to access 13 of 24 PtDAs. Conclusions. Greater attention to health literacy and socially-disadvantaged populations is needed in the field of PtDAs to ensure equity in decision support.
SørensenKVan Den BrouckeSFullamJ, et al. Health literacy and public health: a systematic review and integration of definitions and models. BMC Public Health. 2012;12(1):80.
2.
KutnerMGreenbergEJinYPaulsenC.The Health Literacy of America’s Adults: Results from the 2003 National Assessment of Adult Literacy (NCES 2006-438). Washington (DC): National Center for Education Statistics; 2006.
3.
Australian Bureau of Statistics. Adult Literacy and Life Skills Survey, Summary Results. Canberra: Australian Bureau of Statistics; 2006.
4.
RowlandsGProtheroeJWinkleyJRichardsonMSeedPTRuddR.A mismatch between population health literacy and the complexity of health information: an observational study. Br J Gen Pract. 2015;65(635):e379–86.
5.
SørensenKPelikanJMRöthlinF, et al. Health literacy in Europe: comparative results of the European health literacy survey (HLS-EU). Eur J Public Health. 2015;25(6):1053–8.
6.
StaceyDLégaréFLewisK, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017(4):CD001431.
7.
McCafferyKHolmes-RovnerMSmithS, et al. Addressing health literacy in patient decision aids. BMC Med Inform Decis Making. 2013;13(suppl 2):S10.
8.
BonnerCPatelPFajardoMAZhuangRTrevenaL.Online decision aids for primary cardiovascular disease prevention: systematic search, evaluation of quality and suitability for low health literacy patients. BMJ Open. 2019;9(3):e025173.
9.
SheridanSHalpernDVieraABerkmanNDonahueKCrottyK.Interventions for individuals with low health literacy: a systematic review. J Health Commun. 2011;16:30.
10.
VisscherBBSteunenbergBHeijmansM, et al. Evidence on the effectiveness of health literacy interventions in the EU: a systematic review.(European Union)(Report). BMC Public Health. 2018;18(1).
11.
MastroianniFChenY-CVellarL, et al. Implementation of an organisation-wide health literacy approach to improve the understandability and actionability of patient information and education materials: a pre-post effectiveness study. Patient Educ Couns. 2019;102(9):1656–61.
12.
MoherDLiberatiATetzlaffJAltmanDG.Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151(4):264–9.
13.
StaceyDLégaréFColNF, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014(1).
14.
MartinLTRuderTEscarceJJ, et al. Developing predictive models of health literacy. J Gen Intern Med. 2009;24(11):1211–6.
15.
DurandM-ACarpenterLDolanH, et al. Do interventions designed to support shared decision-making reduce health inequalities? A systematic review and meta-analysis. PloS One. 2014;9(4):e94670.
16.
Ottawa Hospital Research Institute. Decision Aid Inventory Library. Ottawa Hospital Research Institute. Available from: https://decisionaid.ohri.ca/DALI/. Accessed April 2020.
ShoemakerSJWolfMSBrachC.Development of the Patient Education Materials Assessment Tool (PEMAT): a new measure of understandability and actionability for print and audiovisual patient information. Patient Educ Couns. 2014;96(3):395–403.
19.
ShoemakerSJWolfMSBrachC.The Patient Education Materials Assessment Tool (PEMAT) and User’s Guide. Rockville (MD): Agency for Healthcare Research and Quality; 2013.
20.
HigginsJPSavovićJPageMJElbersRGSterneJA.Assessing risk of bias in a randomized trial. In: Cochrane Handbook for Systematic Reviews of Interventions. London: Cochrane Collaboration; 2019:205–28.
21.
BoulwareLEEphraimPLAmelingJ, et al. Effectiveness of informational decision aids and a live donor financial assistance program on pursuit of live kidney transplants in African American hemodialysis patients. BMC Nephrol. 2018;19(1):107.
22.
BrennerATHoffmanRMcWilliamsA, et al. Colorectal cancer screening in vulnerable patients: promoting informed and shared decisions. Am J Prev Med. 2016;51(4):454–62.
23.
DiefenbachMABenedictCMillerSM, et al. Examining the impact of a multimedia intervention on treatment decision-making among newly diagnosed prostate cancer patients: results from a nationwide RCT. Transl Behav Med. 2018;8(6):876–86.
24.
HoffmanASLowensteinLMKamathGR, et al. An entertainment-education colorectal cancer screening decision aid for African American patients: a randomized controlled trial. Cancer. 2017;123(8):1401–8.
25.
IbrahimSABlumMLeeG-C, et al. Effect of a decision aid on access to total knee replacement for Black patients with osteoarthritis of the knee: a randomized clinical trial. JAMA Surg. 2017;152(1):e164225.
26.
JimenezMEDuRivageNEBezpalkoO, et al. A pilot randomized trial of a video patient decision aid to facilitate early intervention referrals from primary care. Clin Pediatr. 2017;56(3):268–77.
27.
Jibaja-WeissMLVolkRJGranchiTS, et al. Entertainment education for breast cancer surgery decisions: a randomized trial among patients with low health literacy. Patient Educ Couns. 2011;84(1):41–8.
28.
KuppermannMNortonMEGatesE, et al. Computerized prenatal genetic testing decision-assisting tool: a randomized controlled trial. Obstet Gynecol. 2009;113(1):53–63.
29.
KuppermannMPenaSBishopJT, et al. Effect of enhanced information, values clarification, and removal of financial barriers on use of prenatal genetic testing: a randomized clinical trial. JAMA. 2014;312(12):1210–7.
30.
LeporeSJWolfRLBaschCE, et al. Informed decision making about prostate cancer testing in predominantly immigrant Black men: a randomized controlled trial. Ann Behav Med. 2012;44(3):320–30.
31.
MarteauTMMannEPrevostAT, et al. Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): randomised trial. BMJ. 2010;340:c2138.
32.
MillerDPSpanglerJGCaseLDGoffDCSinghSPignoneMP.Effectiveness of a web-based colorectal cancer screening patient decision aid: a randomized controlled trial in a mixed-literacy population. Am J Prev Med. 2011;40(6):608–15.
33.
MillerDPJrDenizard-ThompsonNWeaverKE, et al. Effect of a digital health intervention on receipt of colorectal cancer screening in vulnerable patients. Ann Intern Med. 2018;168(8):550.
34.
MyersREDaskalakisCCocroftJ, et al. Preparing African-American men in community primary care practices to decide whether or not to have prostate cancer screening. J Natl Med Assoc. 2005;97(8):1143–54.
35.
RisingKLHollanderJESchafferJT, et al. Effectiveness of a decision aid in potentially vulnerable patients: a secondary analysis of the chest pain choice multicenter randomized trial. Med Decis Making. 2017;38(1):69–78.
36.
RuffinMTFettersMDJimboM.Preference-based electronic decision aid to promote colorectal cancer screening: results of a randomized controlled trial. Prev Med. 2007;45(4):267–73.
37.
SchroyPCEmmonsKPetersE, et al. The impact of a novel computer-based decision aid on shared decision making for colorectal cancer screening: a randomized trial. Med Decis Making. 2011;31(1):93–107.
38.
SmithSKTrevenaLSimpsonJMBarrattANutbeamDMcCafferyKJ.A decision aid to support informed choices about bowel cancer screening among adults with low education: randomised controlled trial. BMJ. 2010;341(7780):977.
39.
StreetRLVoigtBGeyerCManningTSwansonGP.Increasing patient involvement in choosing treatment for early breast cancer. Cancer. 1995;76(11):2275–85.
40.
TaylorKLDavisJLTurnerRO, et al. Educating African American men about the prostate cancer screening dilemma: a randomized intervention. Cancer Epidemiol Biomarkers Prev. 2006;15(11):2179–88.
41.
TrevenaLJIrwigLBarrattA.Randomized trial of a self-administered decision aid for colorectal cancer screening. J Med Screen. 2008;15(2):76–82.
42.
VinaERRichardsonDMedvedevaEKent KwohCCollierAIbrahimSA.Does a patient-centered educational intervention affect African-American access to knee replacement? A randomized trial. Clin Orthop Relat Res. 2016;474(8):1755–64.
43.
VolkRJJibaja-WeissMLHawleyST, et al. Entertainment education for prostate cancer screening: a randomized trial among primary care patients with low health literacy. Patient Educ Couns. 2008;73(3):482–9.
44.
WilliamsRMDavisKMLutaG, et al. Fostering informed decisions: a randomized controlled trial assessing the impact of a decision aid among men registered to undergo mass screening for prostate cancer. Patient Educ Couns. 2013;91(3):329–36.
45.
WolfAMDNasserJFWolfAMSchorlingJB. The impact of informed consent on patient interest in prostate-specific antigen screening. JAMA Intern Med. 1996;156(12):1333–6.
46.
ReulandDSBrennerATHoffmanR, et al. Effect of combined patient decision aid and patient navigation vs usual care for colorectal cancer screening in a vulnerable patient population: a randomized clinical trial. JAMA Intern Med. 2017;177(7):967–74.
47.
Jibaja-WeissMLVolkRJ.Utilizing computerized entertainment education in the development of decision aids for lower literate and naïve computer users. J Health Commun. 2007;12(7):681–97.
48.
MoronySMcCafferyKJKirkendallSJansenJWebsterAC.Health literacy demand of printed lifestyle patient information materials aimed at people with chronic kidney disease: are materials easy to understand and act on and do they use meaningful visual aids?J Health Commun. 2017;22(2):163–70.
GrabeelKLRussomannoJOelschlegelSTesterEHeidelRE.Computerized versus hand-scored health literacy tools: a comparison of Simple Measure of Gobbledygook (SMOG) and Flesch-Kincaid in printed patient education materials. J Med Libr Assoc. 2018;106(1):38–45.
51.
BregaAGBarnardJMabachiNM, et al. AHRQ Health Literacy Universal Precautions Toolkit, Second Edition. Prepared by Colorado Health Outcomes Program, University of Colorado Anschutz Medical Campus under contract No. HHSA290200710008, TO#10. AHRQ Publication No 15-0023-EF. Rockville (MD): Agency for Healthcare Research and Quality; 2015.
52.
SepuchaKRAbhyankarPHoffmanAS, et al. Standards for UNiversal reporting of patient Decision Aid Evaluation studies: the development of SUNDAE Checklist. BMJ Qual Saf. 2018;27(5):380–8.
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