The specific intervention differed in each study. Randomized studies were given the highest quality and those with large sample sizes were considered to have the greatest validity.
The six studies included research participants. Quality Evaluation We evaluated five quality criteria for each study: All scores are presented as the average of the scores on the individual tested questions.
Description of the Intervention We considered an intervention if a study changed the informed consent to improve comprehension. We chose not to use more formal quality rating systems because the best-validated systems are not clearly relevant to this set of trials.
The reviewers also identified one 1 citation for review from full text article references. Two studies changed the readability level of the IC and resulted in the lowest comprehension among study subjects. Definition of Health Literacy The key exposure variable was an intervention used in a low literacy population.
Two of the studies included the teach-back method or teach to goal method and achieved the highest level of comprehension. Our aim is to evaluate the evidence supporting interventions, to improve comprehension of the IC process in low literacy subjects.
Articles were considered for inclusion if they reported on original data where a change in the informed consent was used to improve comprehension about the informed consent for research purposes in low literacy populations.
The main outcome evaluated was comprehension, measured using a written test or verbal comprehension. Therefore, we included only six articles into our systematic review. We excluded on the abstract level and selected 31 for full text review; of the 31 selected for full text review, we included five studies and excluded 26 for the following reasons: This search was conducted by filtering all articles, except those containing key terms such as informed consent, health literacy, research, and comprehension.
Only one study had a randomized design. The studies predominantly included populations that were older median age 61, range 48—64ethnic minority, and with literacy level of 8th grade or below.
We included randomized trials where those changes were evaluated against a control group, and also non-random studies where the comprehension to changes to the consent document or process were evaluated without a control group. Inter-rater agreement between reviewers on inclusion vs.
More specifically, the search was performed by entering: Data Abstraction One investigator was responsible for completing the evidence table LTand the second confirmed the accuracy of the data abstracted AP.
The use of validated tools for these purposes was considered a high quality indicator. Outcome The outcome variable of interest was comprehension, measured using either a written test or verbal comprehension. Our search yielded abstracts.
Selection Criteria Two investigators reviewed the abstract of each identified citation. The method of evaluating the key exposure and outcome are of critical importance.
All searches were conducted in November, and were supplemented by manual searches of bibliographies of key relevant articles. Agreement on whether to review the full text or include the article in the evidence table was calculated using inter-rater agreement.
Literacy was defined by either a validated method of measuring health literacy or self reported educational level. 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.
We selected all studies in which a modification of the IC was tested to improve comprehension in low literacy populations.Free Essay: Informed consent is the basis for all legal and moral aspects of a patient’s autonomy.
Implied consent is when you and your physician interact in. 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.
improve informed consent in clinical research: Feasibility, approach, and results effectiveness of interventions in improving understanding. Methods: Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different research studies,1 the informed consent process allows potential.
This essay has been submitted by a law student. This is not an example of the work written by our professional essay writers. Informed consent ethical issues from not understanding the consent form.
Improving Effectiveness of Informed Consent Process A growing subspecialty of nursing practice is clinical research nursing. According to Harvard’s Catalyst Clinical Research Center (HCCRC) and the National Institutes of Health (NIH) nurses play an active role in providing care within a delivery system that is focused on conducting clinical.
Informed consent is a process by which a fully informed patient can participate in choices of health care. Collingridge, M. () states "it originates from legal and ethical rights patients have to direct what happens to their body and from ethical duty of physician to involve them into their health care"/5(7).Download