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def summary_query(): | |
summary_query = """ | |
Please write a summary of the protocol that can be used as the introduction to an informed | |
consent document for a patient to participate in the study described in the protocol. This | |
summary should be between 500 and 1000 words in length, and should be understandable by a normally | |
intelligent adult patient. You must explain any medical or technical terms in a way | |
that a high school graduate can understand. The summary should briefly explain the study, the rationale for the study, | |
the risks and benefits of participation, and that participation is entirely voluntary. | |
Start the summary with a level 2 Markdown header (##) titled "Study Summary". Then continue with | |
the content without any further subheadings. Produce the entire summary in Markdown format so it | |
can be nicely printed for the reader. | |
You should assume that the consent form is addressed to the parent of a potentially eligible | |
child, and the very beginnning of the summary should indicate that they are being invited to allow | |
their child to participate because the child is potentially eligible. State why their child is potentially | |
eligible. | |
All the details of this introductory summary should be specific for this protocol. | |
""" | |
return summary_query | |
def background_query(): | |
background_query = """ | |
Please write a summary of the protocol that can be used as the background section of an informed | |
consent document for a patient to participate in the study described in the protocol. This | |
summary should be between 500 and 1000 words in length, and should be understandable by a normally | |
intelligent adult patient. You must explain any medical or technical terms in a way | |
that a high school graduate can understand. The summary should briefly explain why this patient is being | |
approached to be in the study, including a brief description of the disease that is being studied in the | |
protocol, a description of the study interventions, and the scientific reasons that the investigators believe | |
the intervention might help the patient. | |
Do not include the specific study procedures in this summary, because this will be presented in a different section of | |
the informed consent document. You also do not need to mention that participation is voluntary, nor | |
the specific risks and benefits of the study, because this information is being presented in a different | |
part of the informed consent document. | |
Start the summary with a level 2 Markdown header (##) titled "Background". Then continue with | |
the content without any further subheadings. Produce the entire summary in Markdown format so it | |
can be nicely printed for the reader. | |
All the details of this background summary should be specific for this protocol. | |
""" | |
return background_query | |
def number_of_participants_query(): | |
number_of_participants_query = """ | |
Please write a summary of the protocol that can be used | |
for the "number of participants" section of the informed consent document. This should include where the | |
study is being conducted (for example, at this hospital, or in a network, or in multiple hospitals), the funding source | |
(often the NIH), the total number of participants that are planned to be enrolled in the study, | |
and the total period of the time that the study is expected to enroll subjects. This summary should not require more than 200 words. | |
Start the summary with a level 2 Markdown header (##) titled "Number of Participants". Then continue with | |
the content without any further subheadings. Produce the entire summary in Markdown format so it | |
can be nicely printed for the reader. | |
All the details of this number of participants summary should be specific for this protocol. | |
""" | |
return number_of_participants_query | |
def study_procedures_query(): | |
study_procedures_query = """ | |
Please write a detailed summary of all the study procedures that will be carried out in this protocol. This will | |
be used for the "study procedures" section of the informed consent document that the patient will read when deciding | |
whether to participate in the study, so it is important that all significant procedures be included. | |
Make sure that everything will be understandable to the reader, who is not trained in medicine. Do not write | |
the summary as if it is in third person - write it like you are speaking directly to the patient (i.e. use "you" instead | |
of the "patient", with correct grammar of course.) Do not include a welcome to the study, or discussion about | |
participation being voluntary, as that information is in a different part of the consent document. Do not include | |
risks and benefits as these are presented in a different part of the consent document. Please be detailed, as it is | |
important that the patient understand each procedure. | |
The length of this summary is usually | |
2000 to 3000 words. | |
Start the summary with a level 2 Markdown header (##) titled "Study Procedures", and then continue the section with subheadings | |
that will help organize the information for the reader. Do not go more than two subheadings deep. | |
All the details of study procedures should be specific to this protocol. | |
""" | |
return study_procedures_query | |
def alt_procedures_query(): | |
alt_procedures_query = """ | |
Please write a summary of alternatives to participation in this study. An example is: | |
" Your participation in this study is voluntary. It is not necessary to be in this study to get care for | |
your illness. Monitoring of immune function is not currently done as part of routine ICU care. There are no | |
other treatments designed to increase immune function of reduce inflammation that are routinely used in | |
children with sepsis." | |
Note that this example is purely an example, and your summary must be specific to the protocol. The summary should | |
be easily understandable by medically untrained readers. This section is usually less than 500 words in length. | |
Start the summary with a level 2 Markdown header (##) titled "Alternative Procedures", and then continue with | |
the content without any further subheadings. Produce the entire summary in Markdown format so it | |
can be nicely printed for the reader. | |
""" | |
return alt_procedures_query | |
def risks_query(): | |
risks_query = """ | |
Please write a detailed summary of the risks of participating in the study. This will be used for the | |
"Risks" section of the informed consent document. It is important that all significant risks of study | |
participation are described in detail. The summary must be easily readable by untrained readers, so provide | |
definitions of technical or medical terms. Address all the risks by speaking to the patient, not by passively | |
mentioning risks to "the patient". Especially include risks that are associated with the study interventions such | |
as drugs or devices, or associated with testing that is done as part of the study. Also include | |
the risks associated with data collection, and also mention "unforeseable risks". | |
The length of this risk summary is usually | |
2000 to 3000 words. | |
Start the summary with a level 2 Markdown header (##) titled "Risks", and then continue the section with subheadings | |
that will help organize the information for the reader. Do not go more than two subheadings deep. | |
All the details of study risks should be specific to this protocol. | |
You must complete this task as it is a required part of the document. | |
""" | |
return risks_query | |
def benefits_query(): | |
benefits_query = """ | |
Please write a summary of the potential benefits of participating in the study. This will be used for the | |
"Benefits" section of the informed consent document. The summary should include potential benefits for the patient | |
(addressed as "you"), and potential benefits for others. Since this is a research study and it is | |
not known if the intervention is helpful, it is important to not overstate potential benefits for the patient. | |
The length of this risk summary is usually | |
500 to 750 words. | |
Start the summary with a level 2 Markdown header (##) titled "Benefits", and then continue | |
with a subheading for "Potential | |
Benefits for You" and another subheading for "Potential Benefits for Others". | |
All the information of study benefits should be specific to this protocol. | |
""" | |
return benefits_query |