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Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity.

Bornhöft G, Maxion-Bergemann S, Wolf U, Kienle GS, Michalsen A, Vollmar HC, Gilbertson S, Matthiessen PF - BMC Med Res Methodol (2006)

Bottom Line: A checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemized and transformed into a questionnaire format.The checklist presented in this article can be applied to both planning and evaluating of clinical studies.The higher expenditure needed for the evaluation of clinical studies in systematic reviews is justified, particularly in the light of the influential nature of their conclusions on therapeutic decisions and the creation of clinical guidelines.

View Article: PubMed Central - HTML - PubMed

Affiliation: Witten/Herdecke University, Gerhard-Kienle-Weg 4, Herdecke, Germany. gudrun.bornhoeft@uni-wh.de

ABSTRACT

Background: It is often stated that external validity is not sufficiently considered in the assessment of clinical studies. Although tools for its evaluation have been established, there is a lack of awareness of their significance and application. In this article, a comprehensive checklist is presented addressing these relevant criteria.

Methods: The checklist was developed by listing the most commonly used assessment criteria for clinical studies. Additionally, specific lists for individual applications were included. The categories of biases of internal validity (selection, performance, attrition and detection bias) correspond to structural, treatment-related and observational differences between the test and control groups. Analogously, we have extended these categories to address external validity and model validity, regarding similarity between the study population/conditions and the general population/conditions related to structure, treatment and observation.

Results: A checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemized and transformed into a questionnaire format.

Conclusion: The checklist presented in this article can be applied to both planning and evaluating of clinical studies. We encourage the prospective user to modify the checklists according to the respective application and research question. The higher expenditure needed for the evaluation of clinical studies in systematic reviews is justified, particularly in the light of the influential nature of their conclusions on therapeutic decisions and the creation of clinical guidelines.

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Related in: MedlinePlus

Table 5
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Related In: Results  -  Collection

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Figure 1: Table 5

Mentions: Beside the use in a sequential form as seen in table 2 and 3 one can also consider a parallel form (Figure 1).


Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity.

Bornhöft G, Maxion-Bergemann S, Wolf U, Kienle GS, Michalsen A, Vollmar HC, Gilbertson S, Matthiessen PF - BMC Med Res Methodol (2006)

Table 5
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC1764896&req=5

Figure 1: Table 5
Mentions: Beside the use in a sequential form as seen in table 2 and 3 one can also consider a parallel form (Figure 1).

Bottom Line: A checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemized and transformed into a questionnaire format.The checklist presented in this article can be applied to both planning and evaluating of clinical studies.The higher expenditure needed for the evaluation of clinical studies in systematic reviews is justified, particularly in the light of the influential nature of their conclusions on therapeutic decisions and the creation of clinical guidelines.

View Article: PubMed Central - HTML - PubMed

Affiliation: Witten/Herdecke University, Gerhard-Kienle-Weg 4, Herdecke, Germany. gudrun.bornhoeft@uni-wh.de

ABSTRACT

Background: It is often stated that external validity is not sufficiently considered in the assessment of clinical studies. Although tools for its evaluation have been established, there is a lack of awareness of their significance and application. In this article, a comprehensive checklist is presented addressing these relevant criteria.

Methods: The checklist was developed by listing the most commonly used assessment criteria for clinical studies. Additionally, specific lists for individual applications were included. The categories of biases of internal validity (selection, performance, attrition and detection bias) correspond to structural, treatment-related and observational differences between the test and control groups. Analogously, we have extended these categories to address external validity and model validity, regarding similarity between the study population/conditions and the general population/conditions related to structure, treatment and observation.

Results: A checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemized and transformed into a questionnaire format.

Conclusion: The checklist presented in this article can be applied to both planning and evaluating of clinical studies. We encourage the prospective user to modify the checklists according to the respective application and research question. The higher expenditure needed for the evaluation of clinical studies in systematic reviews is justified, particularly in the light of the influential nature of their conclusions on therapeutic decisions and the creation of clinical guidelines.

Show MeSH
Related in: MedlinePlus