PP34 Interventions to Promote Informed Consent for Invasive Healthcare Procedures: A Cochrane Systematic Review and Meta-Analysis

Abstract

Background Informed consent is required before any surgery or invasive procedure is performed. Achieving ethically valid informed consent can be difficult: too little information may leave patients poorly informed and too much information may be overwhelming. As such interventions to promote information provision for informed consent are warranted. This study aimed to evaluate the impact of such interventions on a range of outcomes including patient knowledge, anxiety, and satisfaction. Methods Medical databases were searched using keywords and subject headings (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycINFO). Reference lists of included studies were searched. Randomised controlled trials (RCTs) of interventions to promote informed consent for patients undergoing surgical or invasive procedures were included. Studies were dual-assessed. Random effects meta-analyses were conducted for all outcomes with sufficient information. Standardised mean differences summarised the output. Narrative synthesis was also performed. Results 65 RCTs were identified from 12 countries. In total 9,021 patients were randomised into these trials. Interventions employed various formats including written material, audio-visual tools and decision aids. Meta-analyses demonstrated statistically significant improvements in knowledge when measured immediately after interventions, shortly afterwards (between 24 hours and 15 days) and at a later date (15 days or more) (Immediate knowledge SMD 0.53 [95% CI 0.37, 0.69], I2 73%; Short-term knowledge SMD 0.68 [0.42, 0.93], I2 85%; Long-term knowledge SMD 0.78 [0.50, 1.06], I2 82%). Satisfaction with decision making also improved (SMD 2.25 [1.36, 3.15], I2 99% and decisional conflict was reduced (SMD -1.80 [-3.46, -0.14], I2 99%). No statistically significant differences were found for generalised anxiety, anxiety with the consent process or satisfaction with the consent process (generalised anxiety SMD -0.11 [-0.35, -0.01], I2 82%, anxiety with the consent process SMD 0.01 [-0.21, 0.23], I2 70%; satisfaction with the consent process SMD 0.12 [-0.09, 0.32], I2 76%). Conclusion Interventions to promote informed consent consistently improve patient knowledge, an important prerequisite for informed consent and this is achieved without any significant harmful effects. Such interventions can thus be considered effective at promoting informed consent for invasive healthcare procedures. Further studies are necessary to investigate all aspects of informed consent as a unified concept.

Evaluating interventions for informed consent for surgery (ICONS): Protocol for the development of a core outcome set

“…However, the review was limited by the large amount of heterogeneity in the outcomes used to determine the effect of the decision aids in the consent process. Similarly, a Cochrane review of interventions to promote informed consent for invasive procedures concluded that interventions to improve consent consistently improved patient knowledge [ 8 ]. However, although knowledge is clearly an important step in achieving informed consent, the authors of the review found that the tremendous heterogeneity in outcomes measured and how they were recorded made comparisons between studies difficult.…”

Radiographers’ knowledge and attitude toward informed consent

“…However, this task can be delegated to the radiographers, especially where no intervention or invasive technique is required. Nevertheless, it should be notice that radiographers have limited time with the patient and might not have seen the patient before their arrival, making it hard for the patient to give consent on such short notice (5). Therefore, those involved in obtaining the consent form should have adequacy in terms of explaining the procedures in simple language that an ordinary can understand and give consent.…”