Content validation of a modi˜ed translated version of the ......Coraline Claeys˜, P.M. Tulkens˚,...

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Coraline Claeys1, P.M. Tulkens2, J. Nève1, A. Spinewine2 1Institute of Pharmacy, Université Libre de Bruxelles - 2School of Pharmacy, Université Calholique de Louvain, Bruxelles, Belgium Background and Objective Medication discrepancies are specific medication errors related to the transfer of patients between different settings of care. The only vali- dated tool to identify and categorize such discrepancies is the medication discrepancy tool (MDT; Smith, 2004)1. However, the interrater reliability was modest. This could be improved with detailed specifications (fig.1). Content validation of this new version of the MDT is then necessary. Setting Eleven health care professionals (HCPs) (nurse, doctors and pharmacists) interes- ted in the field of patient transfer or having clinical experience in managing pa- tient transition were recruited as experts for the first validation round. Three HCPs (nurse, doctor, and pharmacist) participated in the second round. Main Outcome Measures Results A total of 45 items were comprised in the three sections of the modified instrument (type of discrepancy, cause, and intervention). Items to describe type of discrepancy were added. A definition was given to each section and each item was described with a definition and an example (fig.3). One example describing the use of the tool was also added. After the first content validation round of this new version of the instrument, several modifications were made, including: definitions of the three sections were modified, 9 items were pooled with another item, 2 items were added, and 30 items were modified at title-, definition- or example-level (fig.4). The second round enabled us to validate these modifications. Conclusion Content validation of the modified translated MDT was realised. The next objective will be to calculate the interrater reliability of this new version of the instrument. Content validation of a modified translated version of the medication discrepancy tool Incorrect label: a misprint of the pill bottle conflicts with the prescription in dosage, name or directions. Mainly for pharmaceutical forms prepared in phar- macy or directions for use specified by pharmacist on the drug packaging. Cause of medication discrepancy -> at level system -> incorrect label ITEM Definition is based on • MDT’s authors precision • Literature review • Local adaptation Design The MDT was translated in French and specifications were introduced. Content validity consists of a two-stage process (development and judgment quantification)2. For the first stage, modifications of the new version of the instru- ment were based on a literature review to determine if additional items or sec- tions should be included in the tool. For the second stage, a panel of experts was recruited to assess different aspects of the content of the tool (fig.2). The Content Validity Index (CVI), a measure which indicates the proportion of members who endorsed an element as content valid, was determined. It was calculated at item-(I-CVI) and tool-level (S-CVI)3. Average deviation mean index (ADm) was used to evaluate interrater agreement4. A second round was conducted to assess modifications of the instrument resulting from the first validation round. I-CVI, S-CVI and ADm to determine items to revise or to discard and items to add to the instrument. Acknowledgement C Claeys (Pharm) is Aspirant of the Belgian Fonds National de la Recherche Scientifique. We thank all people that participated in this study. References 1. Smith, J.D., E.A. Coleman, and S.J. Min, A new tool for identifying discrepancies in postacute medications for community-dwelling older adults. Am J Geriatr Pharmacother, 2004. 2(2): p. 141-7. 2. Lynn, M.R., Determination and quantification of content validity. Nurs Res, 1986. 35(6): p. 382-5. 3. Polit, D.F. and C.T. Beck, The content validity index: are you sure you know what's being reported? Critique and recommendations. Res Nurs Health, 2006. 29(5): p. 489-97. 4. Burke MJ and D. WP, Estimating interrater agreement with the average deviation index: A user's guide. Organizational Research Methods, 2002. 5: p. 159-172. Contact Coraline Claeys - [email protected] Keywords content validity, medication discrepancy, instrument fig.1 Exemple of specification fig.3 fig.4 Results of content validation by 11 HCPs for the item «incorrect label» Participants have to rate on a four-point (4) scale or a two point (2) scale different content aspects of the tool fig.2 Content aspects of the modified translated version to assess Representativeness (4) Uniqueness (2) ClarityCompleteness (2) Helpfulness (4) (4) NAME OF ITEM REPRESENTATI VENESS OF ITEM (n = 11) CLARITY OF THE NAME OF ITEM (n=11) CLARITY OF DEFINITION (n=11) UNIQUENESS OF ITEM (n=11) Score 1 2 3 4 1 2 3 4 1 2 3 4 1 2 COMMENTS OF EXPERTS Incorrect label 0 0 3 8 1 0 3 7 1 1 0 9 5 6 E1 : I dont very well understand the sense of item. E2 : Scarce E3 : Is this item is not covered by item «conflicting information from different informational sources» ? E4 : the name of item could be replace by « instruction to patient inaccurate ». But this is the same that item «conflicting information from different informational sources»… E5 : included in item « delivery error »? I-CVI 1 0,9 0,81 0,45 ADm (p-value) 0,39 (0,02) 0,69 (0,1) 0,74 (0,16) 0,49 (1) Conclusion : item “incorrect label” will be pooled with another item of the section “cause of medication discrepancy at system level” Sections and examples of items of each section of the modified version of the MDT after the second round of validation Type of unintentional medication discrepancy identified i.e. : omission, frequency of administration cause at patient level i.e. : financial barriers, self-medication Cause at system level i.e. : instruction to patient inaccurate/incomplete/illegible, instruction to doctor inaccurate/incomplete/illegible Intervention to solve medication discrepancy i.e. : advise the patient to refer to an HCP

Transcript of Content validation of a modi˜ed translated version of the ......Coraline Claeys˜, P.M. Tulkens˚,...

  • Coraline Claeys1, P.M. Tulkens2, J. Nève1, A. Spinewine21Institute of Pharmacy, Université Libre de Bruxelles - 2School of Pharmacy, Université Calholique de Louvain, Bruxelles, Belgium

    Background and Objective

    Medication discrepancies are speci�c medication errors related to the transfer of patients between di�erent settings of care. The only vali-dated tool to identify and categorize such discrepancies is the medication discrepancy tool (MDT; Smith, 2004)1. However, the interrater reliability was modest. This could be improved with detailed speci�cations (�g.1). Content validation of this new version of the MDT is then necessary.

    SettingEleven health care professionals (HCPs) (nurse, doctors and pharmacists) interes-ted in the �eld of patient transfer or having clinical experience in managing pa-tient transition were recruited as experts for the �rst validation round. Three HCPs (nurse, doctor, and pharmacist) participated in the second round.

    Main Outcome Measures

    ResultsA total of 45 items were comprised in the three sections of the modi�ed instrument (type of discrepancy, cause, and intervention). Items to describe type of discrepancy were added. A de�nition was given to each section and each item was described with a de�nition and an example (�g.3). One example describing the use of the tool was also added. After the �rst content validation round of this new version of the instrument, several modi�cations were made, including: de�nitions of the three sections were modi�ed, 9 items were pooled with another item, 2 items were added, and 30 items were modi�ed at title-, de�nition- or example-level (�g.4). The second round enabled us to validate these modi�cations.

    Conclusion

    Content validation of the modi�ed translated MDT was realised. The next objective will be to calculate the interrater reliability of this new version of the instrument.

    Content validation of a modi�ed translated version of the medication discrepancy tool

    Incorrect label: a misprint of the pill bottle con�icts with the prescription in dosage, name or directions. Mainly for pharmaceutical forms prepared in phar-macy or directions for use speci�ed by pharmacist on the drug packaging.

    Cause of medication discrepancy

    -> at level system

    -> incorrect label

    ITEM

    De�nition is based on

    • MDT’s authors precision • Literature review • Local adaptation

    Design

    The MDT was translated in French and speci�cations were introduced. Content validity consists of a two-stage process (development and judgment quanti�cation)2. For the �rst stage, modi�cations of the new version of the instru-ment were based on a literature review to determine if additional items or sec-tions should be included in the tool. For the second stage, a panel of experts was recruited to assess di�erent aspects of the content of the tool (�g.2). The Content Validity Index (CVI), a measure which indicates the proportion of members who endorsed an element as content valid, was determined. It was calculated at item-(I-CVI) and tool-level (S-CVI)3. Average deviation mean index (ADm) was used to evaluate interrater agreement4. A second round was conducted to assess modi�cations of the instrument resulting from the �rst validation round.

    I-CVI, S-CVI and ADm to determine items to revise or to discard and items to add to the instrument.

    Acknowledgement

    C Claeys (Pharm) is Aspirant of the Belgian Fonds National de la Recherche Scienti�que. We thank all people that participated in this study.

    References1. Smith, J.D., E.A. Coleman, and S.J. Min, A new tool for identifying discrepancies in postacute medications for community-dwelling older adults. Am J Geriatr Pharmacother, 2004. 2(2): p. 141-7.2. Lynn, M.R., Determination and quanti�cation of content validity. Nurs Res, 1986. 35(6): p. 382-5.3. Polit, D.F. and C.T. Beck, The content validity index: are you sure you know what's being reported? Critique and recommendations. Res Nurs Health, 2006. 29(5): p. 489-97.4. Burke MJ and D. WP, Estimating interrater agreement with the average deviation index: A user's guide. Organizational Research Methods, 2002. 5: p. 159-172. Contact

    Coraline Claeys - [email protected]

    Keywords

    content validity, medication discrepancy, instrument

    �g.1 Exemple of speci�cation

    �g.3

    �g.4 Results of content validation by 11 HCPs for the item «incorrect label»

    Participants have to rate on a four-point (4) scale or a two point (2) scale di�erent

    content aspects of the tool

    �g.2 Content aspects of the modi�ed translated version to assess

    Representativeness (4)

    Uniqueness

    (2)

    Clarity

    Comp

    leten

    ess

    (2)

    Helpfulness (4)

    (4)

    NAME OF ITEM REPRESENTATI

    VENESS OF ITEM (n = 11)

    CLARITY OF THE NAME OF

    ITEM (n=11)

    CLARITY OF DEFINITION

    (n=11)

    UNIQUENESS OF ITEM (n=11)

    Score 1 2 3 4 1 2 3 4 1 2 3 4 1 2

    COMMENTS OF EXPERTS

    Incorrect label 0 0 3 8 1 0 3 7 1 1 0 9 5 6

    E1 : I don’t very well understand the sense of item. E2 : Scarce E3 : Is this item is not covered by item «con�icting information from di�erent informational sources» ? E4 : the name of item could be replace by « instruction to patient inaccurate ». But this is the same that item «con�icting information from di�erent informational sources»… E5 : included in item « delivery error »?

    I-CVI 1 0,9 0,81 0,45

    ADm (p-value)

    0,39 (0,02) 0,69 (0,1) 0,74 (0,16) 0,49 (1)

    Conclusion : item “incorrect label” will be pooled with another item of the section “cause of medication discrepancy at system level”

    Sections and examples of items of each section of the modi�ed version of the MDT after the second round of validation

    • Type of unintentional medication discrepancy identi�edi.e. : omission, frequency of administration• cause at patient leveli.e. : �nancial barriers, self-medication• Cause at system leveli.e. : instruction to patient inaccurate/incomplete/illegible, instruction to doctor inaccurate/incomplete/illegible • Intervention to solve medication discrepancyi.e. : advise the patient to refer to an HCP