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normal range checks vs Male and female

Dear OC users,
I’m new to OC and I am trying to set up a study where we will collect laboratory tests results and enter them into OC.
My problem is that I want OC to flag all “out of normal range” values, but normal ranges are different for male and female.
Is it possible to set up two different ranges for the same item, and link range to apply with another item?
Did anyone solve this problem before?
Many thanks in advance for your help.

Emeric REYNAUD, MSc
ImmunoClin
Les Cordeliers
15 Rue de l’ecole de Medecine
Escalier E, 2½ étage
75006 PARIS, France
Tel : + 33 (0) 1 46 33 45 35
Fax : +33 (0) 1 72 70 35 44
[email protected]

Comments

  • Dear OC users,
    I’m new to OC and I am trying to set up a study where we will collect laboratory tests results and enter them into OC.
    My problem is that I want OC to flag all “out of normal range” values, but normal ranges are different for male and female.
    Is it possible to set up two different ranges for the same item, and link range to apply with another item?
    Did anyone solve this problem before?
    Many thanks in advance for your help.

    Emeric REYNAUD, MSc
    ImmunoClin
    Les Cordeliers
    15 Rue de l’ecole de Medecine
    Escalier E, 2½ étage
    75006 PARIS, France
    Tel : + 33 (0) 1 46 33 45 35
    Fax : +33 (0) 1 72 70 35 44
    [email protected]
  • rwattsrwatts Posts: 102
    My experience of normal ranges is that they are also dependent on the subject’s age, vary from laboratory to laboratory and could change if equipment is changed or recalibrated during a study. For these reasons I have always validated lab data externally from the EDC system, hopefully having obtained the data in an electronic format from the lab.

    However, to answer your question, you may be able to write rules to perform this validation rather than using the range checks on the CRF template. Rules can reference values on other CRFs in the study, so if you have the subject’s gender on a CRF you can write a rule that’s gender specific. I don’t use rules much so someone else may be able to give you more information on this.

    Is there anyone out there using rules to validate lab data?

    R.
    Sent: March 14, 2011 9:50 AM
    To: [email protected]; [email protected]
    Subject: [Users] normal range checks vs Male and female

    Dear OC users,
    I’m new to OC and I am trying to set up a study where we will collect laboratory tests results and enter them into OC.
    My problem is that I want OC to flag all “out of normal range” values, but normal ranges are different for male and female.
    Is it possible to set up two different ranges for the same item, and link range to apply with another item?
    Did anyone solve this problem before?
    Many thanks in advance for your help.

    Emeric REYNAUD, MSc
    ImmunoClin
    Les Cordeliers
    15 Rue de l’ecole de Medecine
    Escalier E, 2½ étage
    75006 PARIS, France
    Tel : + 33 (0) 1 46 33 45 35
    Fax : +33 (0) 1 72 70 35 44
    [email protected]
  • I would be interested in such a solution as well. We are collecting data of standardized neuropsychological tests. For these tests, we have age and gender specific norm tables that transform raw values into Z statistics.
    Although this is a data postprocessing step, it would be good to have the opportunity to enter raw data and extract either raw or Z values.
    Am 14.03.2011 17:07, schrieb [email protected]:
    > My experience of normal ranges is that they are also dependent on the
    > subject’s age, vary from laboratory to laboratory and could change if
    > equipment is changed or recalibrated during a study. For these reasons I
    > have always validated lab data externally from the EDC system, hopefully
    > having obtained the data in an electronic format from the lab.
    >
    > However, to answer your question, you may be able to write rules to
    > perform this validation rather than using the range checks on the CRF
    > template. Rules can reference values on other CRFs in the study, so if
    > you have the subject’s gender on a CRF you can write a rule that’s
    > gender specific. I don’t use rules much so someone else may be able to
    > give you more information on this.
    >
    > Is there anyone out there using rules to validate lab data?
    >
    > R.
    >
    > *From:*[email protected]
    > [mailto:[email protected]] *On Behalf Of *Emeric Reynaud
    > *Sent:* March 14, 2011 9:50 AM
    > *To:* [email protected]; [email protected]
    > *Subject:* [Users] normal range checks vs Male and female
    >
    > Dear OC users,
    >
    > I’m new to OC and I am trying to set up a study where we will collect
    > laboratory tests results and enter them into OC.
    >
    > My problem is that I want OC to flag all “out of normal range” values,
    > but normal ranges are different for male and female.
    >
    > Is it possible to set up two different ranges for the same item, and
    > link range to apply with another item?
    >
    > Did anyone solve this problem before?
    >
    > Many thanks in advance for your help.
    >
    > Emeric REYNAUD, MSc
    >
    > ImmunoClin
    >
    > Les Cordeliers
    >
    > 15 Rue de l’ecole de Medecine
    >
    > Escalier E, 2½ étage
    >
    > 75006 PARIS, France
    >
    > Tel : + 33 (0) 1 46 33 45 35
    >
    > Fax : +33 (0)1 72 70 35 44
    >
    > [email protected]
    >
    >
    >
    >
  • kristiakkristiak Posts: 1,338 ✭✭✭
    I agree with Rick…there are so many factors that influences a lab value that it is virtually impossible to write an edit check to solve this issue. What we normally do, we have a “soft edit” check that checks the lowest range and the highest regardless of sex. This is a hint to the investigator to check the values that maybe abnormal considering all factors relevant for the patient at hand.

    Regards


    Krister
    Sent: 14 March 2011 17:07
    To: [email protected]
    Subject: Re: [Users] normal range checks vs Male and female

    My experience of normal ranges is that they are also dependent on the subject’s age, vary from laboratory to laboratory and could change if equipment is changed or recalibrated during a study. For these reasons I have always validated lab data externally from the EDC system, hopefully having obtained the data in an electronic format from the lab.

    However, to answer your question, you may be able to write rules to perform this validation rather than using the range checks on the CRF template. Rules can reference values on other CRFs in the study, so if you have the subject’s gender on a CRF you can write a rule that’s gender specific. I don’t use rules much so someone else may be able to give you more information on this.

    Is there anyone out there using rules to validate lab data?

    R.
    Sent: March 14, 2011 9:50 AM
    To: [email protected]; [email protected]
    Subject: [Users] normal range checks vs Male and female

    Dear OC users,
    I’m new to OC and I am trying to set up a study where we will collect laboratory tests results and enter them into OC.
    My problem is that I want OC to flag all “out of normal range” values, but normal ranges are different for male and female.
    Is it possible to set up two different ranges for the same item, and link range to apply with another item?
    Did anyone solve this problem before?
    Many thanks in advance for your help.

    Emeric REYNAUD, MSc
    ImmunoClin
    Les Cordeliers
    15 Rue de l’ecole de Medecine
    Escalier E, 2½ étage
    75006 PARIS, France
    Tel : + 33 (0) 1 46 33 45 35
    Fax : +33 (0) 1 72 70 35 44
    [email protected]
  • sneha2sneha2 Posts: 36
    Emeric,
    We use cross form edit checks to validate the ranges for laboratory parameters with reference to gender.
    Example: if we want the Hematocrit range for males to be between 36-49 and for females to be between 34-46 The expression in the XML document is as follows
    (GENDER eq M and Hematocrit lt 36) or (GENDER eq M and Hematocrit gt 49) or
    (GENDER eq F and Hematocrit lt 34) or (GENDER eq F and Hematocrit gt 46)
    On Mon, Mar 14, 2011 at 9:19 PM, Emeric Reynaud wrote:
    Dear OC users,
    I’m new to OC and I am trying to set up a study where we will collect laboratory tests results and enter them into OC.
    My problem is that I want OC to flag all “out of normal range” values, but normal ranges are different for male and female.
    Is it possible to set up two different ranges for the same item, and link range to apply with another item?
    Did anyone solve this problem before?
    Many thanks in advance for your help.

    Emeric REYNAUD, MSc
    ImmunoClin
    Les Cordeliers
    15 Rue de l’ecole de Medecine
    Escalier E, 2½ étage
    75006 PARIS, France
    Tel : + 33 (0) 1 46 33 45 35
    Fax : +33 (0) 1 72 70 35 44
    [email protected]
  • rwattsrwatts Posts: 102
    The last study I worked on where we needed to do this involved labs from several countries. It was extra work but we had the units and normal ranges entered off the lab reports as well as the results. This allowed us to both review the normal ranges that were in use for the study and validate the results against those ranges. We did the range checking in SAS though…

    Rick.
    Sent: March 15, 2011 6:29 AM
    To: [email protected]
    Subject: Re: [Users] normal range checks vs Male and female

    I agree with Rick…there are so many factors that influences a lab value that it is virtually impossible to write an edit check to solve this issue. What we normally do, we have a “soft edit” check that checks the lowest range and the highest regardless of sex. This is a hint to the investigator to check the values that maybe abnormal considering all factors relevant for the patient at hand.

    Regards


    Krister
    Sent: 14 March 2011 17:07
    To: [email protected]
    Subject: Re: [Users] normal range checks vs Male and female

    My experience of normal ranges is that they are also dependent on the subject’s age, vary from laboratory to laboratory and could change if equipment is changed or recalibrated during a study. For these reasons I have always validated lab data externally from the EDC system, hopefully having obtained the data in an electronic format from the lab.

    However, to answer your question, you may be able to write rules to perform this validation rather than using the range checks on the CRF template. Rules can reference values on other CRFs in the study, so if you have the subject’s gender on a CRF you can write a rule that’s gender specific. I don’t use rules much so someone else may be able to give you more information on this.

    Is there anyone out there using rules to validate lab data?

    R.
    Sent: March 14, 2011 9:50 AM
    To: [email protected]; [email protected]
    Subject: [Users] normal range checks vs Male and female

    Dear OC users,
    I’m new to OC and I am trying to set up a study where we will collect laboratory tests results and enter them into OC.
    My problem is that I want OC to flag all “out of normal range” values, but normal ranges are different for male and female.
    Is it possible to set up two different ranges for the same item, and link range to apply with another item?
    Did anyone solve this problem before?
    Many thanks in advance for your help.

    Emeric REYNAUD, MSc
    ImmunoClin
    Les Cordeliers
    15 Rue de l’ecole de Medecine
    Escalier E, 2½ étage
    75006 PARIS, France
    Tel : + 33 (0) 1 46 33 45 35
    Fax : +33 (0) 1 72 70 35 44
    [email protected]
  • rshieldsrshields Posts: 10
    Another option is to use published book normals such as the AMA manual of style. We've used this successfully for FDA submissions before.
    On Mar 15, 2011, at 7:32 AM, wrote:
    > The last study I worked on where we needed to do this involved labs from several countries. It was extra work but we had the units and normal ranges entered off the lab reports as well as the results. This allowed us to both review the normal ranges that were in use for the study and validate the results against those ranges. We did the range checking in SAS though…
    >
    >
    >
    > Rick.
    >
    >
    >
    >
    > Sent: March 15, 2011 6:29 AM
    > To: [email protected]
    > Subject: Re: [Users] normal range checks vs Male and female
    >
    >
    >
    > I agree with Rick…there are so many factors that influences a lab value that it is virtually impossible to write an edit check to solve this issue. What we normally do, we have a “soft edit” check that checks the lowest range and the highest regardless of sex. This is a hint to the investigator to check the values that maybe abnormal considering all factors relevant for the patient at hand.
    >
    >
    >
    > Regards
    >
    >
    >
    >
    >
    > Krister
    >
    >
    >
    >
    >
    >
    > Sent: 14 March 2011 17:07
    > To: [email protected]
    > Subject: Re: [Users] normal range checks vs Male and female
    >
    >
    >
    > My experience of normal ranges is that they are also dependent on the subject’s age, vary from laboratory to laboratory and could change if equipment is changed or recalibrated during a study. For these reasons I have always validated lab data externally from the EDC system, hopefully having obtained the data in an electronic format from the lab.
    >
    >
    >
    > However, to answer your question, you may be able to write rules to perform this validation rather than using the range checks on the CRF template. Rules can reference values on other CRFs in the study, so if you have the subject’s gender on a CRF you can write a rule that’s gender specific. I don’t use rules much so someone else may be able to give you more information on this.
    >
    >
    >
    > Is there anyone out there using rules to validate lab data?
    >
    >
    >
    > R.
    >
    >
    >
    >
    > Sent: March 14, 2011 9:50 AM
    > To: [email protected]; [email protected]
    > Subject: [Users] normal range checks vs Male and female
    >
    >
    >
    > Dear OC users,
    >
    > I’m new to OC and I am trying to set up a study where we will collect laboratory tests results and enter them into OC.
    >
    > My problem is that I want OC to flag all “out of normal range” values, but normal ranges are different for male and female.
    >
    > Is it possible to set up two different ranges for the same item, and link range to apply with another item?
    >
    > Did anyone solve this problem before?
    >
    > Many thanks in advance for your help.
    >
    >
    >
    > Emeric REYNAUD, MSc
    >
    > ImmunoClin
    >
    > Les Cordeliers
    >
    > 15 Rue de l’ecole de Medecine
    >
    > Escalier E, 2½ étage
    >
    > 75006 PARIS, France
    >
    > Tel : + 33 (0) 1 46 33 45 35
    >
    > Fax : +33 (0) 1 72 70 35 44
    >
    > [email protected]
    >
    >
    >
  • rshieldsrshields Posts: 10
    Another option is to use published book normals such as the AMA manual of style. We've used this successfully for FDA submissions before.
    On Mar 15, 2011, at 7:32 AM, wrote:
    > The last study I worked on where we needed to do this involved labs from several countries. It was extra work but we had the units and normal ranges entered off the lab reports as well as the results. This allowed us to both review the normal ranges that were in use for the study and validate the results against those ranges. We did the range checking in SAS though…
    >
    >
    >
    > Rick.
    >
    >
    >
    >
    > Sent: March 15, 2011 6:29 AM
    > To: [email protected]
    > Subject: Re: [Users] normal range checks vs Male and female
    >
    >
    >
    > I agree with Rick…there are so many factors that influences a lab value that it is virtually impossible to write an edit check to solve this issue. What we normally do, we have a “soft edit” check that checks the lowest range and the highest regardless of sex. This is a hint to the investigator to check the values that maybe abnormal considering all factors relevant for the patient at hand.
    >
    >
    >
    > Regards
    >
    >
    >
    >
    >
    > Krister
    >
    >
    >
    >
    >
    >
    > Sent: 14 March 2011 17:07
    > To: [email protected]
    > Subject: Re: [Users] normal range checks vs Male and female
    >
    >
    >
    > My experience of normal ranges is that they are also dependent on the subject’s age, vary from laboratory to laboratory and could change if equipment is changed or recalibrated during a study. For these reasons I have always validated lab data externally from the EDC system, hopefully having obtained the data in an electronic format from the lab.
    >
    >
    >
    > However, to answer your question, you may be able to write rules to perform this validation rather than using the range checks on the CRF template. Rules can reference values on other CRFs in the study, so if you have the subject’s gender on a CRF you can write a rule that’s gender specific. I don’t use rules much so someone else may be able to give you more information on this.
    >
    >
    >
    > Is there anyone out there using rules to validate lab data?
    >
    >
    >
    > R.
    >
    >
    >
    >
    > Sent: March 14, 2011 9:50 AM
    > To: [email protected]; [email protected]
    > Subject: [Users] normal range checks vs Male and female
    >
    >
    >
    > Dear OC users,
    >
    > I’m new to OC and I am trying to set up a study where we will collect laboratory tests results and enter them into OC.
    >
    > My problem is that I want OC to flag all “out of normal range” values, but normal ranges are different for male and female.
    >
    > Is it possible to set up two different ranges for the same item, and link range to apply with another item?
    >
    > Did anyone solve this problem before?
    >
    > Many thanks in advance for your help.
    >
    >
    >
    > Emeric REYNAUD, MSc
    >
    > ImmunoClin
    >
    > Les Cordeliers
    >
    > 15 Rue de l’ecole de Medecine
    >
    > Escalier E, 2½ étage
    >
    > 75006 PARIS, France
    >
    > Tel : + 33 (0) 1 46 33 45 35
    >
    > Fax : +33 (0) 1 72 70 35 44
    >
    > [email protected]
    >
    >
    >
  • Dear Emeric,
    I think that Sneha has provided a very good example ... I believe you should start by visiting this topic: https://community.openclinica.com/OpenClinica/3.0/doc/5_5_rules_Help.html
    The concept of applying those range checks is very do-able .. but it will take some time to practice and implement.
    Good Luck.
    On 15 March 2011 18:51, Ryan Shields wrote:
    Another option is to use published book normals such as the AMA manual of style. We've used this successfully for FDA submissions before.
    On Mar 15, 2011, at 7:32 AM, wrote:
    > The last study I worked on where we needed to do this involved labs from several countries. It was extra work but we had the units and normal ranges entered off the lab reports as well as the results. This allowed us to both review the normal ranges that were in use for the study and validate the results against those ranges. We did the range checking in SAS though…
    >
    >
    >
    > Rick.
    >
    >
    >
    >
    > Sent: March 15, 2011 6:29 AM
    > To: [email protected]
    > Subject: Re: [Users] normal range checks vs Male and female
    >
    >
    >
    > I agree with Rick…there are so many factors that influences a lab value that it is virtually impossible to write an edit check to solve this issue. What we normally do, we have a “soft edit” check that checks the lowest range and the highest regardless of sex. This is a hint to the investigator to check the values that maybe abnormal considering all factors relevant for the patient at hand.
    >
    >
    >
    > Regards
    >
    >
    >
    >
    >
    > Krister
    >
    >
    >
    >
    >
    >
    > Sent: 14 March 2011 17:07
    > To: [email protected]
    > Subject: Re: [Users] normal range checks vs Male and female
    >
    >
    >
    > My experience of normal ranges is that they are also dependent on the subject’s age, vary from laboratory to laboratory and could change if equipment is changed or recalibrated during a study. For these reasons I have always validated lab data externally from the EDC system, hopefully having obtained the data in an electronic format from the lab.
    >
    >
    >
    > However, to answer your question, you may be able to write rules to perform this validation rather than using the range checks on the CRF template. Rules can reference values on other CRFs in the study, so if you have the subject’s gender on a CRF you can write a rule that’s gender specific. I don’t use rules much so someone else may be able to give you more information on this.
    >
    >
    >
    > Is there anyone out there using rules to validate lab data?
    >
    >
    >
    > R.
    >
    >
    >
    >
    > Sent: March 14, 2011 9:50 AM
    > To: [email protected]; [email protected]
    > Subject: [Users] normal range checks vs Male and female
    >
    >
    >
    > Dear OC users,
    >
    > I’m new to OC and I am trying to set up a study where we will collect laboratory tests results and enter them into OC.
    >
    > My problem is that I want OC to flag all “out of normal range” values, but normal ranges are different for male and female.
    >
    > Is it possible to set up two different ranges for the same item, and link range to apply with another item?
    >
    > Did anyone solve this problem before?
    >
    > Many thanks in advance for your help.
    >
    >
    >
    > Emeric REYNAUD, MSc
    >
    > ImmunoClin
    >
    > Les Cordeliers
    >
    > 15 Rue de l’ecole de Medecine
    >
    > Escalier E, 2½ étage
    >
    > 75006 PARIS, France
    >
    > Tel : + 33 (0) 1 46 33 45 35
    >
    > Fax : +33 (0) 1 72 70 35 44
    >
    > [email protected]
    >
    >
    >
  • Dear Emeric,
    I think that Sneha has provided a very good example ... I believe you should start by visiting this topic: https://community.openclinica.com/OpenClinica/3.0/doc/5_5_rules_Help.html
    The concept of applying those range checks is very do-able .. but it will take some time to practice and implement.
    Good Luck.
    On 15 March 2011 18:51, Ryan Shields wrote:
    Another option is to use published book normals such as the AMA manual of style. We've used this successfully for FDA submissions before.
    On Mar 15, 2011, at 7:32 AM, wrote:
    > The last study I worked on where we needed to do this involved labs from several countries. It was extra work but we had the units and normal ranges entered off the lab reports as well as the results. This allowed us to both review the normal ranges that were in use for the study and validate the results against those ranges. We did the range checking in SAS though…
    >
    >
    >
    > Rick.
    >
    >
    >
    >
    > Sent: March 15, 2011 6:29 AM
    > To: [email protected]
    > Subject: Re: [Users] normal range checks vs Male and female
    >
    >
    >
    > I agree with Rick…there are so many factors that influences a lab value that it is virtually impossible to write an edit check to solve this issue. What we normally do, we have a “soft edit” check that checks the lowest range and the highest regardless of sex. This is a hint to the investigator to check the values that maybe abnormal considering all factors relevant for the patient at hand.
    >
    >
    >
    > Regards
    >
    >
    >
    >
    >
    > Krister
    >
    >
    >
    >
    >
    >
    > Sent: 14 March 2011 17:07
    > To: [email protected]
    > Subject: Re: [Users] normal range checks vs Male and female
    >
    >
    >
    > My experience of normal ranges is that they are also dependent on the subject’s age, vary from laboratory to laboratory and could change if equipment is changed or recalibrated during a study. For these reasons I have always validated lab data externally from the EDC system, hopefully having obtained the data in an electronic format from the lab.
    >
    >
    >
    > However, to answer your question, you may be able to write rules to perform this validation rather than using the range checks on the CRF template. Rules can reference values on other CRFs in the study, so if you have the subject’s gender on a CRF you can write a rule that’s gender specific. I don’t use rules much so someone else may be able to give you more information on this.
    >
    >
    >
    > Is there anyone out there using rules to validate lab data?
    >
    >
    >
    > R.
    >
    >
    >
    >
    > Sent: March 14, 2011 9:50 AM
    > To: [email protected]; [email protected]
    > Subject: [Users] normal range checks vs Male and female
    >
    >
    >
    > Dear OC users,
    >
    > I’m new to OC and I am trying to set up a study where we will collect laboratory tests results and enter them into OC.
    >
    > My problem is that I want OC to flag all “out of normal range” values, but normal ranges are different for male and female.
    >
    > Is it possible to set up two different ranges for the same item, and link range to apply with another item?
    >
    > Did anyone solve this problem before?
    >
    > Many thanks in advance for your help.
    >
    >
    >
    > Emeric REYNAUD, MSc
    >
    > ImmunoClin
    >
    > Les Cordeliers
    >
    > 15 Rue de l’ecole de Medecine
    >
    > Escalier E, 2½ étage
    >
    > 75006 PARIS, France
    >
    > Tel : + 33 (0) 1 46 33 45 35
    >
    > Fax : +33 (0) 1 72 70 35 44
    >
    > [email protected]
    >
    >
    >
This discussion has been closed.