ABSTRACT
BACKGROUND
Inadequate health literacy may impair research subjects’ ability to participate adequately in the informed consent (IC) process. Our aim is to evaluate the evidence supporting interventions, to improve comprehension of the IC process in low literacy subjects.
METHODS
We performed a MEDLINE database search (1966 to November 2011) supplemented by manual searches of bibliographies of key relevant articles. We selected all studies in which a modification of the IC was tested to improve comprehension in low literacy populations. Study design, quality criteria, population, interventions and outcomes for each trial were extracted. The main outcome evaluated was comprehension, measured using a written test or verbal comprehension.
RESULTS
Our search strategy yielded 281 studies, of which only six met our eligibility criteria. The six studies included 1620 research participants. The studies predominantly included populations that were older (median age 61, range 48–64), ethnic minority, and with literacy level of 8th grade or below. Only one study had a randomized design. The specific intervention differed in each study. Two of the studies included the teach-back method or teach to goal method and achieved the highest level of comprehension. Two studies changed the readability level of the IC and resulted in the lowest comprehension among study subjects.
CONCLUSIONS
The evidence supporting interventions to improve the informed consent process in low literacy populations is extremely limited. Among the interventions evaluated, having a study team member spend more time talking one-on-one to study participants was the most effective strategy for improving informed consent understanding; however, this finding is based on the results of a single study.
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REFERENCES
Sugarman J. Missing the informed in consent. Anesth Analg. 2003;96(2):319–20.
Howard JM, DeMets D. How informed is informed consent? the BHAT experience. Control Clin Trials. 1981;2(4):287–303.
Riecken HW, Ravich R. Informed consent to biomedical research in veterans administration hospitals. JAMA. 1982;248(3):344–8.
Sugarman J, Paasche-Orlow M. Confirming comprehension of informed consent as a protection of human subjects. J Gen Intern Med. 2006;21(8):898–9.
Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001;358(9295):1772–7.
Marcus EN. The silent epidemic–the health effects of illiteracy. N Engl J Med. 2006;355(4):339–41.
Dewalt DA, Berkman ND, Sheridan S, Lohr KN, Pignone MP. Literacy and health outcomes: a systematic review of the literature. J Gen Intern Med. 2004;19(12):1228–39.
Paasche-Orlow MK, Wolf MS. The causal pathways linking health literacy to health outcomes. Am J Health Behav. 2007;31(Suppl 1):S19–26.
Gazmararian JA, Williams MV, Peel J, Baker DW. Health literacy and knowledge of chronic disease. Patient Educ Couns. 2003;51(3):267–75.
Wolf MS, Gazmararian JA, Baker DW. Health literacy and health risk behaviors among older adults. Am J Prev Med. 2007;32(1):19–24.
Jackson RD, Eckert GJ. Health literacy in an adult dental research population: a pilot study. J Public Health Dent. 2008;68(4):196–200.
Flory J, Emanuel E. Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA. 2004;292(13):1593–601.
Raich PC, Plomer KD, Coyne CA. Literacy, comprehension, and informed consent in clinical research. Cancer Invest. 2001;19(4):437–45.
Juni P, Witschi A, Bloch R, Egger M. The hazards of scoring the quality of clinical trials for meta-analysis. JAMA. 1999;282(11):1054–60.
Bickmore TW, Pfeifer LM, Paasche-Orlow MK. Using computer agents to explain medical documents to patients with low health literacy. Patient Educ Couns. 2009;75(3):315–20.
Chong SA, Ong YY, Subramaniam M, Abdin E, Marx CE, Campbell AV. An assessment of the understanding and motivations of patients with schizophrenia about participating in a clinical trial. Contemp Clin Trials. 2009;30(5):446–50.
Kripalani S, Bengtzen R, Henderson LE, Jacobson TA. Clinical research in low-literacy populations: using teach-back to assess comprehension of informed consent and privacy information. IRB. 2008;30(2):13–9.
Sudore RL, Landefeld CS, Williams BA, Barnes DE, Lindquist K, Schillinger D. Use of a modified informed consent process among vulnerable patients: a descriptive study. J Gen Intern Med. 2006;21(8):867–73.
Young DR, Hooker DT, Freeberg FE. Informed consent documents: increasing comprehension by reducing reading level. IRB. 1990;12(3):1–5.
Davis TC, Holcombe RF, Berkel HJ, Pramanik S, Divers SG. Informed consent for clinical trials: a comparative study of standard versus simplified forms. J Natl Cancer Inst. 1998;90(9):668–74.
Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med. 2003;348(8):721–6.
Daugherty CK, Banik DM, Janish L, Ratain MJ. Quantitative analysis of ethical issues in phase I trials: a survey interview of 144 advanced cancer patients. IRB. 2000;22(3):6–14.
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Tamariz, L., Palacio, A., Robert, M. et al. Improving the Informed Consent Process for Research Subjects with Low Literacy: A Systematic Review. J GEN INTERN MED 28, 121–126 (2013). https://doi.org/10.1007/s11606-012-2133-2
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DOI: https://doi.org/10.1007/s11606-012-2133-2