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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. | |
| """ | |
| 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 |