Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures

Abstract

Background Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. Purpose To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources A systematic literature search of English-language articles in MEDLINE (1949–2008) and EMBASE (1974–2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection Randomized controlled trials and controlled trials with non-random allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations Many studies failed to include adequate description of the study population, and outcome measures varied widely. Conclusions A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.

Patient Recall 6 Weeks After Surgical Consent for Midurethral Sling Using Mesh

“…Whether or not these scores are an accurate representation of what a reasonable patient would want to know is undetermined, although we did find that lack of risk recall was associated with worsened decision regret 6 weeks following surgery. A meta-analysis of studies investigating methods of improving informed consent reviewed 44 articles and found that a variety of interventions all improved patient comprehension immediately post consent including repeat back methods, written and multimedia interventions, and extended informed consent discussions [12]. In the metaanalysis, most trials examined immediate patient comprehension; fewer studies examined patient recall following their procedure as we did.…”

“…Both our trial and previous trials investigating patient understanding of consent [12] are limited by the choice of how to measure patient understanding. Like previous trials we utilized a checklist "score" of specific questions regarding risks, benefits, alternatives, and procedural items as our measure of understanding.…”

Can a decision aid enable informed decisions in neonatal nursery recruitment for a fragile X newborn screening study?

“…34,35 In this study, we show that a carefully designed set of informational materials can improve parents' attention to them and, for those who do read them, the IDM format can result in lower rates of participation, an indication that the decision-making process has been influenced. The fact that only 14% of the mothers read the entire decision aid brochure is sobering but should be tempered by the recognition that parents use multiple sources of information on which to base decisions.…”

Factors Related to Voluntary Parental Decision-Making in Pediatric Oncology

“…In those studies they used an observer checklist that provides an objective assessment of elements of the protocol discussion. Future research should also determine whether different interventions to enhance parental decision-making, such as anticipatory guidance, 29 physician training, 28 and other modifications such as enhanced consent forms and the use of multimedia, 30 affect voluntariness.…”