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Simplifying consent documents does not affect how well potential participants understand a clinical trial, according to new research.
The study showed no significant difference in comprehension between patients who read a concise consent document and those who read a longer document written at a more advanced reading level.
However, researchers did find that mailing consent forms to patients in advance and explaining the study to patients in person did improve their comprehension.
Christine Grady, PhD, of the NIH Clinical Center in Bethesda, Maryland, and her colleagues reported these findings in PLOS ONE.
The team noted that informed consent is a central tenet of ethical clinical research. However, over time, the documents used to obtain informed consent have grown longer, more complex, and harder to read.
So the researchers developed a concise alternative to consent documents used in the multinational START trial.
The new document was shorter than the old document by almost 70%, at 1821 words. The new document also contained bullet points and tables and had a simpler reading level.
Dr Grady and her colleagues tested the old and new documents with 4229 HIV-positive patients treated at 77 sites seeking enrollment in the START trial between 2009 and 2013.
The sites were randomly allocated to either the concise or the standard consent documents for participants to review.
There was no significant difference in comprehension scores between patients who received the concise form and those who received the standard form (P>0.1). Likewise, there was no significant difference in patient satisfaction or willingness to volunteer (P>0.1).
However, patients who received the concise form were significantly less likely to say the form was too long or too detailed (P<0.001).
The researchers did find several factors that were associated with significantly better comprehension.
Patients had significantly (P<0.05) better comprehension scores if they had a higher education level, were white, were treated at sites with more previous HIV studies, and were treated at sites where staff explained the study and thought patients understood the study very well.
Patients had significantly lower comprehension scores if they were treated at sites that rarely or never mailed the consent form ahead of the clinic visit (P=0.009). 
Simplifying consent documents does not affect how well potential participants understand a clinical trial, according to new research.
The study showed no significant difference in comprehension between patients who read a concise consent document and those who read a longer document written at a more advanced reading level.
However, researchers did find that mailing consent forms to patients in advance and explaining the study to patients in person did improve their comprehension.
Christine Grady, PhD, of the NIH Clinical Center in Bethesda, Maryland, and her colleagues reported these findings in PLOS ONE.
The team noted that informed consent is a central tenet of ethical clinical research. However, over time, the documents used to obtain informed consent have grown longer, more complex, and harder to read.
So the researchers developed a concise alternative to consent documents used in the multinational START trial.
The new document was shorter than the old document by almost 70%, at 1821 words. The new document also contained bullet points and tables and had a simpler reading level.
Dr Grady and her colleagues tested the old and new documents with 4229 HIV-positive patients treated at 77 sites seeking enrollment in the START trial between 2009 and 2013.
The sites were randomly allocated to either the concise or the standard consent documents for participants to review.
There was no significant difference in comprehension scores between patients who received the concise form and those who received the standard form (P>0.1). Likewise, there was no significant difference in patient satisfaction or willingness to volunteer (P>0.1).
However, patients who received the concise form were significantly less likely to say the form was too long or too detailed (P<0.001).
The researchers did find several factors that were associated with significantly better comprehension.
Patients had significantly (P<0.05) better comprehension scores if they had a higher education level, were white, were treated at sites with more previous HIV studies, and were treated at sites where staff explained the study and thought patients understood the study very well.
Patients had significantly lower comprehension scores if they were treated at sites that rarely or never mailed the consent form ahead of the clinic visit (P=0.009).
Simplifying consent documents does not affect how well potential participants understand a clinical trial, according to new research.
The study showed no significant difference in comprehension between patients who read a concise consent document and those who read a longer document written at a more advanced reading level.
However, researchers did find that mailing consent forms to patients in advance and explaining the study to patients in person did improve their comprehension.
Christine Grady, PhD, of the NIH Clinical Center in Bethesda, Maryland, and her colleagues reported these findings in PLOS ONE.
The team noted that informed consent is a central tenet of ethical clinical research. However, over time, the documents used to obtain informed consent have grown longer, more complex, and harder to read.
So the researchers developed a concise alternative to consent documents used in the multinational START trial.
The new document was shorter than the old document by almost 70%, at 1821 words. The new document also contained bullet points and tables and had a simpler reading level.
Dr Grady and her colleagues tested the old and new documents with 4229 HIV-positive patients treated at 77 sites seeking enrollment in the START trial between 2009 and 2013.
The sites were randomly allocated to either the concise or the standard consent documents for participants to review.
There was no significant difference in comprehension scores between patients who received the concise form and those who received the standard form (P>0.1). Likewise, there was no significant difference in patient satisfaction or willingness to volunteer (P>0.1).
However, patients who received the concise form were significantly less likely to say the form was too long or too detailed (P<0.001).
The researchers did find several factors that were associated with significantly better comprehension.
Patients had significantly (P<0.05) better comprehension scores if they had a higher education level, were white, were treated at sites with more previous HIV studies, and were treated at sites where staff explained the study and thought patients understood the study very well.
Patients had significantly lower comprehension scores if they were treated at sites that rarely or never mailed the consent form ahead of the clinic visit (P=0.009).